AccessGUDID - DEVICE: Alleset (16931918123073)

GUDID

Device Identifier (DI) Information

Brand Name: Alleset
Version or Model: Model 25-0562
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRI Medical & Electronic Technology Co., Ltd.

Primary DI Number: 16931918123073
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 400
Labeler D-U-N-S® Number*: 679894738 *Terms of Use

Device Description: 9" Sponge Forceps_Nylon_Green_400ea/cs

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?
62490	Dressing/utility forceps, scissors-like, single-use	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	FORCEPS, 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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 70b0d6db-3138-4348-b04b-fcef2eaaa4cd
Public Version Date: June 02, 2023
Public Version Number: 2
DI Record Publish Date: February 27, 2021