AccessGUDID - DEVICE: EAR HOOK (B974EH1000S03)

GUDID

Device Identifier (DI) Information

Brand Name: EAR HOOK
Version or Model: LILIE EAR HOOK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EH1000S
Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,

Primary DI Number: B974EH1000S03
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645680125 *Terms of Use

Device Description: LILIE EAR HOOK 18CM (7") 1MM BALL, 90 DG

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?
64022	Soft-tissue surgical hook, single-use	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	Instrument, Ent Manual Surgical

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: 18 Centimeter

Device Record Status

Public Device Record Key: 129296d3-c331-4a1a-a1f7-0cd8e55ca89a
Public Version Date: November 29, 2022
Public Version Number: 1
DI Record Publish Date: November 21, 2022