FDA.reportPublic FDA data

Cutimed® Cuticell®

Primary DI
04042809809725
Brand
Cutimed® Cuticell®
Company
BSN medical GmbH
Model
71007-03
Catalog number
71007-03
Device description
CUTIMED CUTICELL STERILE 7.5CMX20CM 50
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, wound, occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042809809725PackageGS16In Commercial Distribution
04042809224269PreviousGS10
04042809809701PrimaryGS10
04042809809640Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809809725040428098097254042809809725
04042809224269040428092242694042809224269
04042809809701040428098097014042809809701
04042809809640040428098096404042809809640

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter
Width7.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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Primary DI, Brand, Company table
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