FDA.reportPublic FDA data

Tex-Care Medical

Primary DI
00632195001083
Brand
Tex-Care Medical
Company
Flynt/Amtex, Inc.
Model
91100-404
Device description
4X4 COTTON 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
00632195001083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00632195001083006321950010836321950010830632195001083

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
00632195000659Tex-Care Medical91856-2042021-12-15
00632195001694Tex-Care Medical91856-3042021-12-15
00632195002462Tex-Care Medical91856-4042021-12-15
00632195002479Tex-Care Medical91856-6042021-12-15
00632195002486Tex-Care Medical91857-2042021-12-15
00632195002493Tex-Care Medical91857-3042021-12-15
00632195002509Tex-Care Medical91857-4042021-12-15
00632195002516Tex-Care Medical91857-6042021-12-15
30632195000001Tex-Care Medical91100-6502021-10-29
20632195000011Tex-Care Medical91100-8502021-10-29
30632195000025Tex-Care Medical91310-1252021-10-29
30632195000032Tex-Care Medical91310-2252021-10-29
30632195000049Tex-Care Medical91310-3252021-10-29
30632195000056Tex-Care Medical91310-4252021-10-29
30632195000063Tex-Care Medical91310-5252021-10-29
30632195000070Tex-Care Medical91310-6252021-10-29
30632195000087Tex-Care Medical91310-8252021-10-29
30632195000094Tex-Care Medical91311-0252021-10-29
30632195000100Tex-Care Medical91311-2252021-10-29
30632195000117Tex-Care Medical91320-1252021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40080196284192MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
40080196832331MEDLINEMEDLINE INDUSTRIES, INC.ITG2026-01-22
50192253045862WebrilCardinal Health 200, LLCITG2025-09-23
50192253045879WebrilCardinal Health 200, LLCITG2025-09-23
50192253045886WebrilCardinal Health 200, LLCITG2025-09-23
50192253045923WebrilCardinal Health 200, LLCITG2025-09-23
16975675788557RESCUE ESSENTIALSEMSRUN GROUPITG2025-07-18
07290100665619Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665626Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665633Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
07290100665640Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDITG2025-07-08
00840117344389CurPro Undercast Padding, 100% Polyester, 2" x 4 yd Dynarex CorporationITG2025-06-05
00810180842099CurPro Undercast Padding , 100% Polyester, 3" x 4 yd Dynarex CorporationITG2025-06-05
00810180842105CurPro Undercast Padding, 100% Polyester, 4" x 4 yd Dynarex CorporationITG2025-06-05
00810180842112CurPro Undercast Padding, 100% Polyester, 6" x 4 yd Dynarex CorporationITG2025-06-05
00810180842129CurPro Undercast Padding, 100% Polyester, 8" x 4 ydDynarex CorporationITG2025-06-05
20192253045755CurityCardinal Health 200, LLCITG2025-03-19
50192253045763CurityCardinal Health 200, LLCITG2025-03-19
20192253045779CurityCardinal Health 200, LLCITG2025-03-19
20192253045793CurityCardinal Health 200, LLCITG2025-03-19
00840117342019CurPro Tubular Elastic Dressing Retention Net, 1/2" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342026CurPro Tubular Elastic Dressing Retention Net, 1 1/2" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342033CurPro Tubular Elastic Dressing Retention Net, 2.3" x 25 yd.Dynarex CorporationITG2025-02-17
00840117342040CurPro Tubular Elastic Dressing Retention Net, 3.2" x 25 yd. Dynarex CorporationITG2025-02-17
50885632106512MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50885632106536MediChoiceOWENS & MINOR DISTRIBUTION, INC.ITG2025-01-09
50197106823017CARDINAL HEALTHCardinal Health 200, LLCITG2024-12-04
06430053260238WOODCASTDassiet OyITG2024-08-11
06430053260252WOODCASTDassiet OyITG2024-08-11
06430053265837WOODCASTDassiet OyITG2024-08-11