AccessGUDID - DEVICE: CLAW GRASPING/EXTRACTING FORCEP INSERT (B0992901242S0)

GUDID

Device Identifier (DI) Information

Brand Name: CLAW GRASPING/EXTRACTING FORCEP INSERT
Version or Model: 2901-242S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B0992901242S0
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: CLAW GRASPING/EXTRACTING FORCEPS SINGLE-ACTION JAW FOR TUBE SHAFT

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):	Yes
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
Laparoscopic grasping forceps, reusable	A rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles that may include a ratchet mechanism; a long slender shaft; and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., duckbill, alligator) controlled by a knob at the handle. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Laparoscopic grasping forceps, reusable

A rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles that may include a ratchet mechanism; a long slender shaft; and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., duckbill, alligator) controlled by a knob at the handle. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002877	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

[?]

Size Type Text
Length: 330 Millimeter
Device Size Text, specify: 5mm Shaft
Device Size Text, specify: 2x3 Teeth

Device Record Status

Public Device Record Key: 3c556872-8cb9-42c2-a44f-fdd5d8a398e7
Public Version Date: July 06, 2018
Public Version Number: 7
DI Record Publish Date: August 19, 2016