AccessGUDID - DEVICE: Alleset (16931918182711)

GUDID

Device Identifier (DI) Information

Brand Name: Alleset
Version or Model: Model 45355-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRI Medical & Electronic Technology Co., Ltd.

Primary DI Number: 16931918182711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 679894738 *Terms of Use

Device Description: Surgical_Towel_ non-woven_Blue_53x63cm- sterile_40ea/cs(2ea/bag,20bag/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?
14077	Surgical towel	A sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / Sponge,Nonresorbable For External Use

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: Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: 4728cd7c-e24d-4dc6-ae2a-ecbe0abd439c
Public Version Date: October 03, 2024
Public Version Number: 2
DI Record Publish Date: March 08, 2021