DEVICE: n.a. (04048551257531)

Device Identifier (DI) Information

n.a.
26188FL
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551257531
GS1

1
315731430 *Terms of Use
Thread Guide, large curvature, bendable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Suture/needle passer, reusable A hand-held manual surgical instrument designed for passing (driving) sutures and suture needles through tissues/prosthetic materials to facilitate suturing (it is not dedicated to ophthalmic applications). A passer, also known as a needle driver, is a long, thin, rod-like device that may be flexible or rigid in design and have hooks, catches, clasps, or forceps-like jaws at the distal end that grip/hold. The distal end will typically terminate as a button, rounded, or acorn tip, while the proximal end will have a handle or lever that is operated by the user. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K946359 000
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Sterilization

No
Yes
Sterilization Method [?]
Peracetic Acid
Ethylene Oxide
Hydrogen Peroxide
Moist Heat or Steam Sterilization
Liquid Chemical
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Record Status

1f3d1117-27e5-4b78-af95-324fb46e3e6c
July 06, 2018
4
September 23, 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
No Package DIs found
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Secondary DI

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

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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

[?]
No Customer Contact currently defined
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