DEVICE: SLS-CLIP (00366162400021)

Device Identifier (DI) Information

SLS-CLIP
O4120-1
In Commercial Distribution
O4120-1
VITALITEC SURGICAL
00366162400021
GS1

1
262783206 *Terms of Use
Titanium Hemostatic Clip - Large Size
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ligation clip, metallic A sterile, metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.
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FDA Product Code

[?]
Product Code Product Code Name
FZP Clip, Implantable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store the unopened sterile package in a cool, dry area, with good ventilation away from areas of extreme temperature and humidity.
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Clinically Relevant Size

[?]
Size Type Text
Height: 12.3 Millimeter
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Device Record Status

56c2be2c-40b8-458a-a1ce-afe1d645af85
March 29, 2018
2
September 17, 2015
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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
03661624006426 44 03661624000226 In Commercial Distribution grouping carton
03661624000226 20 00366162400021 In Commercial Distribution clinical box
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
508-7476033
eknuppesi@aol.com
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