FDA.reportPublic FDA data

Texas Medical Technology

Primary DI
00850032920568
Brand
Texas Medical Technology
Company
Texas Medical Technology Inc
Model
3PLY-PRCMSK-04
Catalog number
3PLY-PRCMSK-04
Device description
3PLY Procedure Mask; surgical mask
Published
2022-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032920568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032920568008500329205688500329205680850032920568

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
346-351-9009omri.shafran@texasmedicaltechnology.com

Regulatory Flags#

DUNS number
117479714
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850032920483Texas Medical TechnologyGWL-04-SMS-SGWL-04-SMS-S2021-12-16
00850032920490Texas Medical TechnologyGWL-04-SMS-MGWL-04-SMS-M2021-12-16
00850032920506Texas Medical TechnologyGWL-04-SMS-LGWL-04-SMS-L2021-12-16
00850032920513Texas Medical TechnologyGWL-04-SMS-XLGWL-04-SMS-XL2021-12-16
00850032920520Texas Medical TechnologyGWL-04-SMS-2XLGWL-04-SMS-2XL2021-12-16
00850032920452Texas Medical TechnologyGWS-03-3XL-BGWS-03-3XL-B2021-10-28
00850032920469Texas Medical TechnologyGWS-03-4XL-BGWS-03-4XL-B2021-10-28
00850032920476Texas Medical TechnologyGWS-03-5XL-BGWS-03-5XL-B2021-10-28
00850022960321Texas Medical TechnologyGWS-03-M-BGWS-03-M-B2021-02-16
00850022960338Texas Medical TechnologyGWS-03-L-BGWS-03-L-B2021-02-16
00850022960345Texas Medical TechnologyGWS-03-XL-BGWS-03-XL-B2021-02-16
00850022960352Texas Medical TechnologyGWS-03-XXL-BGWS-03-XXL-B2021-02-16
00850022960369Texas Medical TechnologyGWS-03-S-BGWS-03-S-B2021-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G539MM3S1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3S2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB1Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
G539MM3SB2Saf-T-GardSaf-T-Gard International, Inc.FXX2026-09-21
00050428143315CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
00050428340561CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFXX2026-09-18
10304040195472EssentialsHENRY SCHEIN, INC.FXX2026-09-04
10304040195489EssentialsHENRY SCHEIN, INC.FXX2026-09-04
00810194402623AiraAIRA, LLCFXX2026-08-26
20197344219237MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-31
06974960061330S&JXiantao S&J Protective Products Co., LtdFXX2026-07-29
00840456202814JMUJMU DENTAL, INCFXX2026-07-24
00840456202807JMUJMU DENTAL, INCFXX2026-07-23
00840456214664JMUJMU DENTAL, INCFXX2026-07-23
00840456214671JMUJMU DENTAL, INCFXX2026-07-23
00840456214688JMUJMU DENTAL, INCFXX2026-07-23
00840456214695JMUJMU DENTAL, INCFXX2026-07-23
30197344201697MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-07-20
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30