FDA.reportPublic FDA data

Cutimed® Siltec®

Primary DI
04042809555868
Brand
Cutimed® Siltec®
Company
BSN medical GmbH
Model
73285-00
Catalog number
73285-00
Device description
CUTIMED SILTEC STERILE 5X6CM 10
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
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
04042809555868PackageGS110In Commercial Distribution
04042809555851PrimaryGS10
04042809703443Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809555868040428095558684042809555868
04042809555851040428095558514042809555851
04042809703443040428097034434042809703443

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Centimeter
Width5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
342651662
Device count
10
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

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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