FDA.reportPublic FDA data

Cuticell®

Primary DI
04042809224214
Brand
Cuticell®
Company
BSN medical GmbH
Model
72539-00
Catalog number
72539-00
Device description
CUTICELL STERILE 7.5CMX7.5CM 1 10/BOX
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

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
04042809224214PackageGS160In Commercial Distribution
04042809226690PackageGS110In Commercial Distribution
04042809224207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809224214040428092242144042809224214
04042809226690040428092266904042809226690
04042809224207040428092242074042809224207

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
Length7.5Centimeter
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
1
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
04042809533590Cutimed® Sorbion®73278-0073278-002022-12-08
04250569302022Cutimed® Epiona®73227-0373227-032025-07-01
04250569302053Cutimed® Epiona®73227-0473227-042025-07-01
04250569302084Cutimed® Epiona®73227-0573227-052025-07-01
04042809670158Cutimed® Sorbion®73232-6873232-682024-09-16
04042809685015Cutimed® Sorbion®73232-6973232-692024-09-16
04042809809596Cutimed® Cuticell®71007-0171007-012024-08-07
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20885632495868HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495875HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496742HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496766HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
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