AccessGUDID - DEVICE: PFAB SMALL (00856525007365)

GUDID

Device Identifier (DI) Information

Brand Name: PFAB SMALL
Version or Model: PFAB-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PFAB-S
Company Name: SUN SCIENTIFIC, INC.

Primary DI Number: 00856525007365
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 609397224 *Terms of Use

Device Description: Silicone Foam Dressing with Air Bolster

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:	Yes
Prescription Use (Rx):	Yes
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?
44970	Exudate-absorbent dressing, non-gel, non-antimicrobial	A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHW	Dressing, Compression
MGP	Dressing, Wound And Burn, Occlusive
NAC	Dressing, Wound, Hydrophilic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070457	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 4b398bc5-b820-4564-bebb-267fc78161e4
Public Version Date: January 01, 2025
Public Version Number: 4
DI Record Publish Date: April 30, 2021