DEVICE: Sterimed (00850341007899)
Device Identifier (DI) Information
Sterimed
VC1018B
In Commercial Distribution
STERIMED LLC
VC1018B
In Commercial Distribution
STERIMED LLC
Video Camera Cover with Blue Elastic Tip 10" X 18", Non-Sterile
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? |
---|---|---|---|---|
37450 | Camera cover, single-use |
A sterile device made of a material, typically of plastic and shaped to fit the camera, which is used as a physical barrier on a camera to protect it from environmental exposure and/or allow the camera to be used in a sterile surgical field. 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
53936e01-61b0-42a0-bced-bf13d395b3b7
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 |
---|---|---|---|---|---|
10850341007896 | 150 | 00850341007899 | In Commercial Distribution | Case |
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