FDA.report

Cutimed® Sorbion®

Primary DI
04042809651690
Brand
Cutimed® Sorbion®
Company
BSN medical GmbH
Model
73232-14
Catalog number
73232-14
Device description
CUTIMED SORBION SACHET S STERILE 15X15CM 50
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042809651690PackageGS16In Commercial Distribution
04042809551310PrimaryGS10
04042809650457Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042809651690040428096516904042809651690
04042809551310040428095513104042809551310
04042809650457040428096504574042809650457

GMDN Terms

TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Length15Centimeter
Width15Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)537-1063HMS.ORDERS@ESSITY.COM

Regulatory Flags

DUNS number
342651662
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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04042809670158Cutimed® Sorbion®73232-6873232-682024-09-16
04042809685015Cutimed® Sorbion®73232-6973232-692024-09-16
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04042809809626Cutimed® Cuticell®71007-0071007-002024-08-07
04042809809657Cutimed® Cuticell®71007-0271007-022024-08-07
04042809809688Cutimed® Cuticell®71007-0471007-042024-08-07
04042809809725Cutimed® Cuticell®71007-0371007-032024-08-07
04042809658996Leukoplast®76450-1476450-142024-04-17
04042809668063Leukoplast®76450-1776450-172024-04-17
04042809668087Leukoplast®76450-1976450-192024-04-17
04042809668117Leukoplast®76450-2276450-222024-04-17
04042809686616Leukoplast®76454-0276454-022024-04-17
04042809686647Leukoplast®76454-0576454-052024-04-17
04042809686678Leukoplast®76454-0876454-082024-04-17
04042809670226Leukoplast®76457-0876457-082024-04-17
04042809670233Leukoplast®76457-0976457-092024-04-17
04042809688344Leukoplast®76455-1176455-112024-04-17

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