FDA.reportPublic FDA data

SureSeal

Primary DI
00894743001017
Brand
SureSeal
Company
FACET TECHNOLOGIES, LLC
Model
Large
Catalog number
85100
Device description
SureSeal Pressure Bandage, 25mm x 72mm
Published
2019-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

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
00089473001035PackageGS120In Commercial Distribution
00894743001017PrimaryGS10
01089473001010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089473001035000894730010350894730010350089473001035
00894743001017008947430010178947430010170894743001017
01089473001010010894730010101089473001010

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, sterileA sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
130518376
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830006705NeatNickPreemie203008P2026-06-01
00382830006712NeatNickFull Term203008FT2026-06-01
00894743001338Facet Medical Technologies010800101080012020-09-26
00894743001345Facet Medical Technologies010800201080022020-09-26
00894743001369Facet Medical Technologies011000101100012020-04-29
00894743001376Facet Medcial Technologies011000201100022020-04-29
00894743001024SureSealExtra Large852002019-07-02
00894743001000CAREFINE11000312017-03-10
00894743001147CAREFINE11000392017-03-10
00894743001703CAREFINE11000002017-03-10
00894743001710CAREFINE11000032017-03-10
00894743001727CAREFINE11000072017-03-10
00894743001734CAREFINE11000152017-03-10
00894743001741CAREFINE11000132017-03-10
00894743001758CAREFINE11000172017-03-10
00894743001765CAREFINE11000332017-03-10
00894743001772CAREFINE11000292017-03-10
00894743001789CAREFINE11000272017-03-10
00894743001796CAREFINE11000412017-03-10
00894743001802CAREFINE11000372017-03-10

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