FDA.reportPublic FDA data

Leukomed® Sorbact®

Primary DI
04042809657647
Brand
Leukomed® Sorbact®
Company
BSN medical GmbH
Model
76199-19
Catalog number
76199-19
Device description
LEUKOMED SORBACT STERILE 10X30CM TRANSPARENT 20 US HOSP
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042809657647PackageGS18In Commercial Distribution
04042809657630PrimaryGS10
04042809657654Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809657647040428096576474042809657647
04042809657630040428096576304042809657630
04042809657654040428096576544042809657654

GMDN Terms#

Term, Definition table
TermDefinition
Microbe-binding hydrophobic dressingA sterile wound covering intended to remove microorganisms (bacteria, fungi) from a wound site through hydrophobic binding, and subsequent dressing removal/exchange. It is a fabric material (e.g., cellulose acetate, cotton) available in various forms, with a strongly hydrophobic surface (e.g., covered by a fatty acid ester). It is intended to be applied to a variety of clean, contaminated, colonized or infected wounds (e.g., trauma wounds, surgical wounds, diabetic ulcers, pressure ulcers, burns) to reduce the levels of microorganisms and promote wound healing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter
Width10Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
342651662
Device count
20
DM exempt
false
Premarket exempt
false
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
false
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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00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
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00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
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00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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