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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37839 Suturing unit, reusable
A non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a reusable device.
Active false
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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
No CLOSE

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

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

1f3d1117-27e5-4b78-af95-324fb46e3e6c
December 04, 2020
6
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

[?]
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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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