DEVICE: Sterimed (00850341007899)

Device Identifier (DI) Information

Sterimed
VC1018B
In Commercial Distribution

STERIMED LLC
00850341007899
GS1

1
080284658 *Terms of Use
Video Camera Cover with Blue Elastic Tip 10" X 18", Non-Sterile
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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
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FDA Product Code

[?]
Product Code Product Code Name
IZI System, X-Ray, Angiographic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K853044 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Radiation Sterilization
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

53936e01-61b0-42a0-bced-bf13d395b3b7
December 18, 2023
3
September 19, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
770-387-0771
xx@xx.xx
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