FDA.reportPublic FDA data

Tensospray®

Primary DI
04042809003338
Brand
Tensospray®
Company
BSN medical GmbH
Model
71602-00
Catalog number
71602-00
Device description
TENSOSPRAY 300 ML 1
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042809003338PackageGS112In Commercial Distribution
04042809003314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809003338040428090033384042809003338
04042809003314040428090033144042809003314

GMDN Terms#

Term, Definition table
TermDefinition
Skin surface device adhesiveA substance (e.g., gel, aerosol) intended to adhere a medical device (e.g., dressing, ostomy device, aesthetic restoration prosthesis) to the skin surface; it is not intended for invasive/surgical use but may be intended for other non-patient contact uses. It may be used in the home or healthcare facility. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume300Milliliter

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18
00050428143216CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-08-18
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17