AccessGUDID - DEVICE: Single Use Scissor (B974111400)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use Scissor
Version or Model: EPISIOTOMY SCISSORS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11140
Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,

Primary DI Number: B974111400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645680125 *Terms of Use

Device Description: EPISIOTOMY SCISSORS 5-1/2"

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:	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62555	Episiotomy scissors, single-use	A hand-held, manual, obstetrical, surgical instrument intended to cut the outlet of the vagina in childbirth so as to facilitate the birth of the child (also known as perineotomy). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are typically angled, have different shapes, and may be serrated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOH	Instrument, Manual, General Obstetric-Gynecologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 5.5 Inch

Device Record Status

Public Device Record Key: 45907695-5145-4168-98ce-f0efb7da75fc
Public Version Date: November 30, 2022
Public Version Number: 1
DI Record Publish Date: November 22, 2022