AccessGUDID - DEVICE: Avaline Medical NJ LLC (00667605028268)

GUDID

Device Identifier (DI) Information

Brand Name: Avaline Medical NJ LLC
Version or Model: tri-ban12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: tri-ban12
Company Name: Avaline Medical NJ Limited Liability Company

Primary DI Number: 00667605028268
Issuing Agency: GS1
Commercial Distribution End Date: June 28, 2022
Device Count: 12
Labeler D-U-N-S® Number*: 079767953 *Terms of Use

Device Description: Triangular Bandages 40" x 40" x 56" x36

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
62041	First aid limb splint, non-mouldable, single-use	A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It consists of an unpadded, non-mouldable rigid portion which is applied externally to the limb and held in place with straps/ropes, and may be capable or applying traction; it is made of a variety of materials, and may be used in the home or by emergency medical services (EMS). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEC	Bandage, liquid, skin protectant

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: 1559e4e7-9398-4446-9e94-649bc988886c
Public Version Date: June 29, 2022
Public Version Number: 2
DI Record Publish Date: March 23, 2022