FDA.reportPublic FDA data

Cutimed® Epiona®

Primary DI
04250569302077
Brand
Cutimed® Epiona®
Company
BSN medical GmbH
Model
73227-05
Catalog number
73227-05
Device description
"CUTIMED EPIONA STERILE 20CMX20CM WHITE 10 USA 8X8"""
Published
2025-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250569302084PackageGS15In Commercial Distribution
04042809434576PreviousGS10
04250569302077PrimaryGS10
04250569302060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250569302084042505693020844250569302084
04042809434576040428094345764042809434576
04250569302077042505693020774250569302077
04250569302060042505693020604250569302060

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Centimeter
Width20Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
342651662
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042809394429Cutimed®72610-0372610-032022-12-08
04042809557305Cutimed® Siltec®73286-0173286-012022-12-08
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

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Primary DI, Brand, Company table
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