DEVICE: WECK (04026704599745)

Device Identifier (DI) Information

WECK
IPN006431
In Commercial Distribution
382800
TELEFLEX INCORPORATED
04026704599745
GS1

6
002348191 *Terms of Use
DURAHOOK 1/4 HOOK 10 PACKAGES PER BOX /6 HOOKS PER PACKAGE
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Device Characteristics

Labeling does not contain MRI Safety Information
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?
47991 Self-retaining surgical retractor, single-use
A sterile, hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HAO INSTRUMENT, SURGICAL, NON-POWERED
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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

[?]
Size Type Text
Width: 0.25 Inch
Length: 4.5 Inch
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Device Record Status

1b29b69f-3560-469a-9eef-c983504f5fa5
January 29, 2020
2
May 15, 2018
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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
44026704599743 10 24026704599749 2020-01-20 Not in Commercial Distribution Case
24026704599749 60 04026704599745 2020-01-20 Not 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: 14026704599742 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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