AccessGUDID - DEVICE: Foam T Medium (00849405031123)

GUDID

Device Identifier (DI) Information

Brand Name: Foam T Medium
Version or Model: XF-MFOAM1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENADYNE BIOTECHNOLOGIES INC.

Primary DI Number: 00849405031123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006616130 *Terms of Use

Device Description: Genadyne Green Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device.

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?
47406	Negative-pressure wound therapy system foam dressing, non-antimicrobial	A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OMP	Negative Pressure Wound Therapy Powered Suction Pump

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092992	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
Length: 10 Centimeter
Width: 15 Centimeter
Depth: 2 Centimeter

Device Record Status

Public Device Record Key: 9c6aa62c-41bf-4f3e-b39e-323707e11ca4
Public Version Date: June 19, 2020
Public Version Number: 4
DI Record Publish Date: September 27, 2016