AccessGUDID - DEVICE: JEDMED (M633351705QHR0)

GUDID

Device Identifier (DI) Information

Brand Name: JEDMED
Version or Model: 35-1705 QHR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 35-1705 QHR
Company Name: JEDMED INSTRUMENT COMPANY

Primary DI Number: M633351705QHR0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092987189 *Terms of Use

Device Description: SCISSORS ALLIG HOUSE-BELLUCCI RIGHT

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33414	Ear scissors, reusable	A long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZB	Scissors, Ear

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65a1a37c-51a6-4bb8-98ad-2e8a7466f76c
Public Version Date: September 09, 2020
Public Version Number: 1
DI Record Publish Date: September 01, 2020