AccessGUDID - DEVICE: ACTISORB® SILVER 220 (15051978002734)

GUDID

Device Identifier (DI) Information

Brand Name: ACTISORB® SILVER 220
Version or Model: 650220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 650220
Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED

Primary DI Number: 15051978002734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 211352227 *Terms of Use

Device Description: Antimicrobial Binding Dressing

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?
47475	Odour-absorbent dressing, antimicrobial	A pad covering for malodourous wounds or lesions (e.g., venous leg ulcers, fungating carcinomas, infected surgical wounds), that absorbs the bad odours typically through a layer of activated charcoal, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. Given the types of wounds to which it is typically applied, the device may also contain a layer that absorbs heavy exudates, and one that minimizes adherence to the wound. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

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
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Width: 6.5 Centimeter
Length: 9.5 Centimeter

Device Record Status

Public Device Record Key: 31419b8f-f51c-4e5f-9693-96d408ecc6da
Public Version Date: September 09, 2020
Public Version Number: 3
DI Record Publish Date: September 24, 2019