AccessGUDID - DEVICE: NovoSorb MTX (09349155002608)

GUDID

Device Identifier (DI) Information

Brand Name: NovoSorb MTX
Version or Model: MTX-0505
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: POLYNOVO BIOMATERIALS PTY LIMITED

Primary DI Number: 09349155002608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 752326723 *Terms of Use

Device Description: NovoSorb® MTX is a biodegradable polyurethane porous matrix supplied in various sizes, ranging from 4cm2 to 800cm2. NovoSorb® MTX is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in an aluminized pouch contained in a cardboard envelope. NovoSorb® MTX can be used where a delay in normal wound healing is not considered necessary by the treating physician, e.g., definitive wound closure by secondary intention.

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 [?]
K221686	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: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 5 Centimeter
Length: 5 Centimeter

Device Record Status

Public Device Record Key: fc9232d9-ecb1-444c-87a3-28b0b10c7305
Public Version Date: June 25, 2024
Public Version Number: 1
DI Record Publish Date: June 17, 2024