AccessGUDID - DEVICE: PROFORE 18-25CM ANKLE CIRC. Case 8 (05031844000746)

GUDID

Device Identifier (DI) Information

Brand Name: PROFORE 18-25CM ANKLE CIRC. Case 8
Version or Model: 66000016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66000016
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05031844000746
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Multi-layer Compression Bandage System

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):	Yes
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?
62744	Wound dressing kit, non-medicated	A collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	Bandage, Elastic

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: 032df423-ed8a-460f-ad7f-92e96e177055
Public Version Date: September 07, 2023
Public Version Number: 4
DI Record Publish Date: April 09, 2020