DEVICE: WECK (14026704917089)

Device Identifier (DI) Information

WECK
IPN928369
In Commercial Distribution
544253
TELEFLEX INCORPORATED
14026704917089
GS1

3
002348191 *Terms of Use
HEMOLOK EXTRA LARGE CLIPS 3/CARTRIDGE 42/BOX
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Device Characteristics

MR Safe
No
No
Yes
Yes
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?
56711 Ligation clip, synthetic polymer, non-bioabsorbable
A non-metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel or a tissue bundle for permanent occlusion. It is typically made of plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and may be designed with a self-locking catch. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries, but is usually not intended for fallopian tube occlusion. Its non-metallic design makes it more compatible with radiological imaging than metallic clips. A dedicated, disposable clip applier may be included.
Active true
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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 [?]
K133202 000
No CLOSE

Sterilization

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

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

[?]
Size Type Text
Length: 0.78 Inch
Width: 0.7 Inch
Depth: 0.15 Inch
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Device Record Status

c0b389b4-0eb6-4596-9357-b51d4f792c40
December 25, 2023
1
December 15, 2023
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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
44026704917080 12 34026704917083 In Commercial Distribution Case
34026704917083 14 14026704917089 In Commercial Distribution 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: 24026704917086 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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