FDA.reportPublic FDA data

Tex-Care Medical

Primary DI
30632195000247
Brand
Tex-Care Medical
Company
Flynt/Amtex, Inc.
Model
91300-650
Device description
6X50YD BIAS
Published
2021-10-29
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
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
30632195000247PackageGS16In Commercial Distribution
00632195000246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3063219500024730632195000247
00632195000246006321950002466321950002460632195000246

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
Radiation Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
038730060
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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007073874969823M™3M Deutschland GmbHITG2026-05-08
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
307073877914223M™ Scotchcast™3M COMPANYITG2022-12-08