FDA.reportPublic FDA data

Cutimed® Sorbion®

Primary DI
04042809551587
Brand
Cutimed® Sorbion®
Company
BSN medical GmbH
Model
73233-07
Catalog number
73233-07
Device description
CUTIMED SORBION SANA STERILE 12X22CM 25
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, wound, hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042809652116PackageGS110In Commercial Distribution
04042809551587PrimaryGS10
04042809649635Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809652116040428096521164042809652116
04042809551587040428095515874042809551587
04042809649635040428096496354042809649635

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length22Centimeter
Width12Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
342651662
Device count
25
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941094081039Cutimed®72636-3572636-352026-03-26
06941094081244Cutimed®72635-3472635-342026-03-26
06941094081312Cutimed®72636-3472636-342026-03-26
06941094081367Cutimed®72636-3672636-362026-03-26
06941094081411Cutimed®72635-3672635-362026-03-26
06941094081473Cutimed®72635-3372635-332026-03-26
06941094081503Cutimed®72636-3772636-372026-03-26
06941094081572Cutimed®72635-3572635-352026-03-26
04042809293043Cutimed®72635-0072635-002022-12-08
04042809293067Cutimed®72635-0172635-012022-12-08
04042809293081Cutimed®72635-0272635-022022-12-08
04042809293104Cutimed®72635-0372635-032022-12-08
04042809293128Cutimed®72636-0072636-002022-12-08
04042809293142Cutimed®72636-0172636-012022-12-08
04042809293166Cutimed®72636-0272636-022022-12-08
04042809687491Leukoplast®76467-0076467-002022-12-08
04042809687514Leukoplast®76466-0076466-002022-12-08
04042809553666Cutimed® Siltec®73283-0073283-002022-12-08
04042809557435Cutimed® Siltec®73288-0073288-002022-12-08
04042809557466Cutimed® Siltec®73288-0173288-012022-12-08

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