AccessGUDID - DEVICE: Suprathel® CW (04260184022557)

GUDID

Device Identifier (DI) Information

Brand Name: Suprathel® CW
Version or Model: Suprathel CW 2x2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 210202-US, 250202-US
Company Name: Polymedics Innovations GmbH

Primary DI Number: 04260184022557
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344089540 *Terms of Use

Device Description: Suprathel® CW is an absorbable, micro-porous membrane and alloplastic skin substitute for the treatment of wounds, including pressure and venous ulcers, venous stasis and diabetic ulcers, ulcers caused by mixed vascular etiologies.

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:	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?
64853	Synthetic wound matrix dressing	A sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QSZ	Absorbable Synthetic Wound Dressing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090160	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
Storage Environment Temperature: between -20 and 22 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25e9a870-8f44-4835-b07a-8219e0041711
Public Version Date: October 21, 2024
Public Version Number: 1
DI Record Publish Date: October 11, 2024