AccessGUDID - DEVICE: ULNAR NERVE PROTECTOR (G0648317270016631)

GUDID

Device Identifier (DI) Information

Brand Name: ULNAR NERVE PROTECTOR
Version or Model: 831727001663
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 831727001663
Company Name: Walgreen Health Solutions, LLC

Primary DI Number: G0648317270016631
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 116685742 *Terms of Use

Device Description: ULNAR NERVE PROTECTOR, Arm Friction/Impact Protector, One Size, Set of 2

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):	No
Over the Counter (OTC):	Yes
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?
44284	Arm friction/impact protector	A device designed to be worn over some length of the arm (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb and its skin from friction and knocks against objects. It is typically made of fabric or soft padded materials and is held in place with bands or straps around the arm, or has a tubular sleeve design; it is not dedicated to the elbow. It is typically used by persons who have thinning skin or skin sores on their elbows/arms, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: 34e73cf2-0ee5-4b54-b8d7-58da1f34ed62
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022