DEVICE: KOCHER CLAMP INSERT (B0992901271S0)

Device Identifier (DI) Information

KOCHER CLAMP INSERT
2901-271S
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B0992901271S0
HIBCC

1
040729840 *Terms of Use
KOCHER CLAMP DOUBLE-ACTION JAW FOR TUBE SHAFT
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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
Vascular Doppler clamp An instrument with an integrated ultrasound transducer used for the detection and temporary occlusion of blood vessels during a surgical procedure. It is typically a held-hand device that is placed on the vasculature to be affected. It is connected to an appropriate signal receiver, and using the Doppler effect (variation in the frequency of a wave of energy (as measured by an observer) due to relative motion between the observer and the source of the wave), will provide the user with information regarding achieved occlusion of the vessel(s). It is typically used on uterine arteries during laparoscopic myomectomy. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat 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
Length: 330 Millimeter
Device Size Text, specify: 10mm Shaft
Device Size Text, specify: 50mm Jaw
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Device Record Status

e7910681-2066-46c5-aa23-0771807adf1b
May 01, 2018
3
August 19, 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

[?]
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

[?]
800-821-7496
info@sontecinstruments.com
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