DEVICE: GOMCO CIRCUMCISION CLAMP (B099540392B0)

Device Identifier (DI) Information

GOMCO CIRCUMCISION CLAMP
540-392B
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B099540392B0
HIBCC

1
040729840 *Terms of Use
BLACK GOMCO CIRCUMCISION CLAMP
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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
Surgical penis clamp, reusable A hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HFX Clamp, Circumcision
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K040052 000
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Sterilization

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
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
Lumen/Inner Diameter: 13 Millimeter
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Device Record Status

fd56d432-74d4-4fe9-85b6-dbfa7ea76092
July 06, 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

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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

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