AccessGUDID - DEVICE: ELMED (00842180178779)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: 24-0094
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 24-0094
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180178779
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: Micro Blunt Hook 8" Overall Length, 3" Knurled Handle, Tapered 3-3/4 Distal shaft with 60deg angled 1mm Tip that is 1/4" long, Tapered Proximal End Starting at 6mm down to 4mm with a flat blunt end – 1" long, Surgical Grade Autoclavable Stainless Steel

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?
42595	Soft-tissue surgical hook, reusable	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 reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDG	Hook, Surgical, General & Plastic Surgery

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: 87383765-7ea7-41c4-b274-cc8f414a3947
Public Version Date: October 13, 2023
Public Version Number: 1
DI Record Publish Date: October 05, 2023