DEVICE: Sterimed (00850341007202)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
43071 | X-ray system cover |
A sterile piece of material used to cover an x-ray system during a surgical procedure to create a sterile barrier between the sterile operating field and the x-ray system, or the prominent parts of the x-ray system that intrude the sterile field. Since x-ray systems cannot be sterilized, this device is draped over/attached to the x-ray system allowing its use without compromising the sterile field. It will also protect the x-ray system from patient contaminants. It is available in a variety of shapes and sizes. This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IZI | System, X-Ray, Angiographic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K853044 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
10520093-96e1-4706-bbfc-acf9510a069e
December 18, 2023
3
September 19, 2016
December 18, 2023
3
September 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20850341007206 | 8 | 10850341007209 | In Commercial Distribution | Case | |
10850341007209 | 25 | 00850341007202 | In Commercial Distribution | Inner Pack/Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
770-387-0771
xx@xx.xx
xx@xx.xx