AccessGUDID - DEVICE: BLACK MICRO ARTERY CLAMP PAIR (B0992100DC3AB0)

GUDID

Device Identifier (DI) Information

Brand Name: BLACK MICRO ARTERY CLAMP PAIR
Version or Model: 2100-DC-3AB
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B0992100DC3AB0
Issuing Agency: HIBCC
Commercial Distribution End Date: June 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: BLACK MICRO ARTERY CLAMP PAIR ANGLED

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Soft-tissue surgical forceps, scissors-like, reusable	A hand-held, manual, open surgical instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

Soft-tissue surgical forceps, scissors-like, reusable

A hand-held, manual, open surgical instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

FDA Product Code

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Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092544	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 16 Millimeter
Device Size Text, specify: 1-2.2mm

Device Record Status

Public Device Record Key: 1c285044-2c5d-4495-a616-72b5b1f6f5c6
Public Version Date: July 06, 2018
Public Version Number: 7
DI Record Publish Date: August 19, 2016