FDA.report

Tex-Care Medical

Primary DI
00632195001502
Brand
Tex-Care Medical
Company
Flynt/Amtex, Inc.
Model
91120-624
Device description
6X24 DP STKT
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

Related Records

Product Codes

CodeName
IPMCover, Limb

Product Code Classifications

CodeDeviceSpecialtyClass
IPMCover, LimbPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00632195001502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00632195001502006321950015026321950015020632195001502

GMDN Terms

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
Ethylene Oxide;Radiation Sterilization

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 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 DIBrandCompanyProduct codePublished
20809160489885Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-08-01
20809160489465Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.IPM2025-07-31
08717127934409Arion Easy-Slide Arion Holding B.V.IPM2025-02-03
08717127934416Arion MagnideArion Holding B.V.IPM2025-02-03
08717127934423Arion Sim-Slide Arion Holding B.V.IPM2025-02-03
08717127934430Arion Easy-OffArion Holding B.V.IPM2025-02-03
08717127934447Arion Easy-Slide ArmArion Holding B.V.IPM2025-02-03
08717127934454Arion Proth-ProArion Holding B.V.IPM2025-02-03
08717127930111Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930401Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930432Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930463Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930494Arion Easy-Slide Arion Holding B.V.IPM2025-01-13
08717127930555Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930586Arion MagnideArion Holding B.V.IPM2025-01-13
08717127930616Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930647Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930678Arion Magnide 2in1Arion Holding B.V.IPM2025-01-13
08717127930708Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930739Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930760Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930791Arion Sim-Slide Arion Holding B.V.IPM2025-01-13
08717127930821Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930852Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930883Arion Easy-OffArion Holding B.V.IPM2025-01-13
08717127930913Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930944Arion Easy-Slide ArmArion Holding B.V.IPM2025-01-13
08717127930975Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931002Arion SlideXArion Holding B.V.IPM2025-01-13
08717127931040Arion SlideXArion Holding B.V.IPM2025-01-13