FDA.reportPublic FDA data

Tex-Care Medical

Primary DI
00632195001090
Brand
Tex-Care Medical
Company
Flynt/Amtex, Inc.
Model
91100-405
Device description
4X5 COTTON BIAS
Published
2021-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITGBandage, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00632195001090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00632195001090006321950010906321950010900632195001090

GMDN Terms#

Term, Definition table
TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast or splint; or to cover a stump when a prosthesis is worn. This is a single-use device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Radiation Sterilization""]"
Ethylene Oxide;Radiation Sterilization

Regulatory Flags#

DUNS number
038730060
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00632195000000Tex-Care Medical91100-6502021-10-29
00632195000017Tex-Care Medical91100-8502021-10-29
00632195000024Tex-Care Medical91310-1252021-10-29
00632195000031Tex-Care Medical91310-2252021-10-29
00632195000048Tex-Care Medical91310-3252021-10-29
00632195000055Tex-Care Medical91310-4252021-10-29
00632195000062Tex-Care Medical91310-5252021-10-29
00632195000079Tex-Care Medical91310-6252021-10-29
00632195000086Tex-Care Medical91310-8252021-10-29
00632195000093Tex-Care Medical91311-0252021-10-29
00632195000109Tex-Care Medical91311-2252021-10-29
00632195000116Tex-Care Medical91320-1252021-10-29
00632195000123Tex-Care Medical91320-2252021-10-29
00632195000130Tex-Care Medical91320-3252021-10-29
00632195000147Tex-Care Medical91320-4252021-10-29
00632195000154Tex-Care Medical91320-5252021-10-29
00632195000161Tex-Care Medical91320-6252021-10-29
00632195000178Tex-Care Medical91320-8252021-10-29
00632195000185Tex-Care Medical91321-0252021-10-29
00632195000192Tex-Care Medical91321-2252021-10-29

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Primary DI, Brand, Company table
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007073874969993M™3M Deutschland GmbHITG2026-05-08
087114280529303M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529543M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280529923M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530363M™ Scotchcast™Solventum US LLCITG2026-04-18
087114280530503M™ Scotchcast™Solventum US LLCITG2026-04-18
10080196284191MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10080196832330MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
10192253045864WebrilCardinal Health 200, LLCITG2025-09-23
10192253045871WebrilCardinal Health 200, LLCITG2025-09-23
10192253045888WebrilCardinal Health 200, LLCITG2025-09-23
10192253045925WebrilCardinal Health 200, LLCITG2025-09-23
00840117344396"CurPro Undercast Padding , 100% Polyester, 3"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344402"CurPro Undercast Padding, 100% Polyester, 4"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344419"CurPro Undercast Padding, 100% Polyester, 6"" x 4 yd "Dynarex CorporationITG2025-06-05
00840117344426"CurPro Undercast Padding, 100% Polyester, 8"" x 4 yd"Dynarex CorporationITG2025-06-05
10885632106545MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-16
10885632106514MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10885632106538MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
10197106823019CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
10080196745616MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196745661MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-13
10080196284184MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10080196824779MedlineMEDLINE INDUSTRIES, INC.ITG2023-10-12
10197106447994CARDINAL HEALTHCardinal Health 200, LLCITG2023-10-12
307073877914153M™ Scotchcast™3M COMPANYITG2022-12-08
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