AccessGUDID - DEVICE: Cutimed® Sorbact® (07392130002263)

GUDID

Device Identifier (DI) Information

Brand Name: Cutimed® Sorbact®
Version or Model: 72611-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72611-30
Company Name: BSN medical GmbH

Primary DI Number: 07392130002263
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 342651662 *Terms of Use

Device Description: CUTIMED SORBACT GEL STERILE 8"X10" GREEN 5 US

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: 25 Centimeter
Width: 20 Centimeter

Device Record Status

Public Device Record Key: f871008d-7ef4-4b93-a6e4-797bb857ef4f
Public Version Date: February 05, 2024
Public Version Number: 1
DI Record Publish Date: January 26, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
07392130003765	6	07392130002263		In Commercial Distribution	shipping case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 07392130001976 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)537-1063
Email: HMS.ORDERS@ESSITY.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES