DEVICE: Batrik Non-Sterile White Clamp Jaw Cover (00690521013834)

Device Identifier (DI) Information

Batrik Non-Sterile White Clamp Jaw Cover
912-1001-100
In Commercial Distribution
912-1001-100
Batrik Medical Manufacturing Inc
00690521013834
GS1

1
243880700 *Terms of Use
"Clamp Jaw Covers, Radio Opaque, Non-Sterile, White, 0.2"" x 5"" / 0.51cm x 12.7cm"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
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?
43387 Clamp jaw cover, non-sterile
A non-sterile device used in pairs that are placed/fitted onto the distal working end (the jaws) of surgical instruments (e.g., vascular clamps, haemostats and forceps) to provide improved atraumatic grip and even pressure distribution when clamping an artery or a vein. It is typically a long device designed as a cylindrical tube and made of radiopaque silicone materials; it is available in various sizes. Sterilization takes place along with the instrument prior to the procedure. It may also be known as jaw covers. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
HCF Instrument, Ligature Passing And Knot Tying
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep awy from sunlight
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Clinically Relevant Size

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

5f727410-6f2d-494f-9027-9e953ad9db3e
November 05, 2021
1
October 28, 2021
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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
No Package DIs found
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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
Yes
No CLOSE

Customer Contact

[?]
514-631-7988
info@surgmed.com
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