FDA.reportPublic FDA data

Tex-Care Medical

Primary DI
00632195000321
Brand
Tex-Care Medical
Company
Flynt/Amtex, Inc.
Model
81151-248
Device description
12X48 IMP STKT
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
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955749000TEX-CARE STERILE STOCKINETTEFlynt Amtex, Inc.1996-11-22KKX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00632195000321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00632195000321006321950003216321950003210632195000321

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). 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
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
Primary DIBrandCompanyProduct codePublished
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08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196025893MEDLINEMEDLINE INDUSTRIES, INC.KKX2022-10-03
10080196496563Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
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10080196497713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
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10080196311033MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196325825MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196333950MedlineMEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196571932MedlineMEDLINE INDUSTRIES, INC.KKX2021-01-26
10080196744213MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-11
10080196748150MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-10
10080196747115MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-09