AccessGUDID - DEVICE: Leukomed® Sorbact® (07392130003574)

GUDID

Device Identifier (DI) Information

Brand Name: Leukomed® Sorbact®
Version or Model: 76199-40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 76199-40
Company Name: BSN medical GmbH

Primary DI Number: 07392130003574
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 342651662 *Terms of Use
Previous DI: 04042809657630

Device Description: LEUKOMED SORBACT STERILE 10CMX30CM 20 US HOSP

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
58741	Microbe-binding hydrophobic dressing	A sterile wound covering intended to remove microorganisms (bacteria, fungi) from a wound site through hydrophobic binding, and subsequent dressing removal/exchange. It is a fabric material (e.g., cellulose acetate, cotton) available in various forms, with a strongly hydrophobic surface (e.g., covered by a fatty acid ester). It is intended to be applied to a variety of clean, contaminated, colonized or infected wounds (e.g., trauma wounds, surgical wounds, diabetic ulcers, pressure ulcers, burns) to reduce the levels of microorganisms and promote wound healing. 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
Length: 30 Centimeter
Width: 10 Centimeter

Device Record Status

Public Device Record Key: 914ae283-a9a9-43a6-a211-034b7b38ba03
Public Version Date: February 05, 2024
Public Version Number: 1
DI Record Publish Date: January 26, 2024