AccessGUDID - DEVICE: SpecuLume (00816908010627)

GUDID

Device Identifier (DI) Information

Brand Name: SpecuLume
Version or Model: 7-34222
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7-34222
Company Name: CYALUME TECHNOLOGIES, INC.

Primary DI Number: 00816908010627
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 154779748 *Terms of Use

Device Description: Self Illuminated Vaginal Speculum (Medium, Screw Closure)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37468	Vaginal speculum, single-use	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIC	Speculum, Vaginal, Nonmetal, Fiberoptic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 40 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d634b0a1-a26f-4621-93da-1daed49a75c9
Public Version Date: January 04, 2023
Public Version Number: 4
DI Record Publish Date: April 05, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20816908010621	4	10816908010624	2023-01-01	Not in Commercial Distribution	Case
10816908010624	25	00816908010627	2023-01-01	Not in Commercial Distribution	Inner Pack