AccessGUDID - DEVICE: NU-GEL® (15051978010005)

GUDID

Device Identifier (DI) Information

Brand Name: NU-GEL®
Version or Model: MNG415U
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MNG415U
Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED

Primary DI Number: 15051978010005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 211352227 *Terms of Use

Device Description: Hydrogel with Alginate

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?
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 8 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 15 Gram

Device Record Status

Public Device Record Key: 938aede6-f550-40ec-96a8-b53484c26866
Public Version Date: September 09, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2019