AccessGUDID - DEVICE: NuMed Industries LLC. (00819123010571)

GUDID

Device Identifier (DI) Information

Brand Name: NuMed Industries LLC.
Version or Model: NM5050COL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Numed Industries, LLC

Primary DI Number: 00819123010571
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964438910 *Terms of Use

Device Description: Type I Collagen is the most abundant type of collagen in the human body. As the main component of connective tissue, it is the most abundant protein in mammals, making up from 25% to 35% of the whole-body protein content. Collagen, in the form of elongated fibrils, is mostly found in fibrous tissues such as tendons, bones, ligaments and skin. The fibroblast is the most common cell which creates collagen. During wound healing, collagen encourages the deposition and organization of newly formed collagen fibers and granulation tissue in the wound bed. It also stimulates new tissue development and wound debridement, creating an environment conducive to healing. NuMed Collagen Dressings are made of a porous type 1, 100% bovine collagen membrane. They consist of a fibrous collagen network similar to the dermis, creating an environment conducive to healing.

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?
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Wound Dressing With Animal-Derived Material(S)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 4.5 Inch
Width: 3.5 Inch
Depth: 1.5 Inch

Device Record Status

Public Device Record Key: 44a0bd48-ff11-46a7-9e24-3582c846ee49
Public Version Date: February 13, 2023
Public Version Number: 1
DI Record Publish Date: February 04, 2023