AccessGUDID - DEVICE: 3M™ Actisorb™ (04054596955288)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ Actisorb™
Version or Model: 190220
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190220
Company Name: 3M Deutschland GmbH

Primary DI Number: 04054596955288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 315731711 *Terms of Use

Device Description: 3M™ Actisorb™ Silver 220 Antimicrobial Binding Dressing, 190220, 10.5 cm x 19.0 cm (4.2 in x 7.6 in), 10/Ct, 5 Ct/Cs

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d77732c8-1a47-4e93-9cdb-2e679e4959a8
Public Version Date: December 29, 2023
Public Version Number: 1
DI Record Publish Date: December 21, 2023