AccessGUDID - DEVICE: Leukomed® Sorbact® (04042809657661)

GUDID

Device Identifier (DI) Information

Brand Name: Leukomed® Sorbact®
Version or Model: 76199-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 76199-20
Company Name: BSN medical GmbH

Primary DI Number: 04042809657661
Issuing Agency: GS1
Commercial Distribution End Date: January 22, 2029
Device Count: 20
Labeler D-U-N-S® Number*: 342651662 *Terms of Use

Device Description: LEUKOMED SORBACT STERILE 10X35CM TRANSPARENT 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":	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?
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
Width: 10 Centimeter
Length: 35 Centimeter

Device Record Status

Public Device Record Key: 78d88ada-dbb5-4bd0-9b8a-0571d75d640d
Public Version Date: January 23, 2024
Public Version Number: 3
DI Record Publish Date: December 08, 2022