DEVICE: RAMIREZ ENDOSCOPIC FOREHEAD CORRUGATOR MALLEABLE GRASPER (B099280000040)

Device Identifier (DI) Information

RAMIREZ ENDOSCOPIC FOREHEAD CORRUGATOR MALLEABLE GRASPER
2800-0004
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B099280000040
HIBCC

1
040729840 *Terms of Use
RAMIREZ ENDOSCOPIC FOREHEAD CORRUGATOR MALLEABLE GRASPER STRAIGHT SHAFT VERTICAL
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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 bulldog clamp, reusable A hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping however it is not dedicated to a specific anatomy/surgery. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
HTD Forceps
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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
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
Device Size Text, specify: 15cm Shaft
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Device Record Status

540792f9-55ae-4c49-98c8-58ff6a3b79db
April 27, 2018
5
August 26, 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

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