FDA.reportPublic FDA data

TUTEM

Primary DI
10817583020489
Brand
TUTEM
Company
ALPHA PRO TECH INC
Model
6055-14 FUTURE DESIGN
Catalog number
6055-14 FUTURE DESIGN
Device description
EARLOOP, TUTEM- FUTURE DESIGN
Published
2016-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K875172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875172000DISPOSABLE SURGICAL FACE MASKIrema USA , Ltd.1988-01-22FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817583020489PackageGS13000In Commercial Distribution
00817583020482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081758302048910817583020489
00817583020482008175830204828175830204820817583020482

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-355-5816XX@XX.XX
1-520-281-0127XX@XX.XX

Regulatory Flags#

DUNS number
003687733
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20817583020752Critical Cover SH-71222-B SH-71222-B2018-07-16
20817583020769Critical CoverSH-71223-BSH-71223-B2018-07-16
20817583020776Critical Cover SH-91182-B SH-91182-B2018-07-16
20817583020790Critical Cover SH-91183-B SH-91183-B2018-07-16
20817583020813Critical Cover SH-91184-B SH-91184-B2018-07-16
20817583020837Critical Cover SH-C1103-B SH-C1103-B2018-07-16
20817583020844Critical Cover SH-E1312-BH SH-E1312-BH2018-07-16
20817583020868Critical Cover SH-E1315-BH SH-E1315-BH2018-07-16
20817583020882Critical Cover SH-E1712-BH SH-E1712-BH2018-07-16
20817583020899Critical Cover SH-E1713-BH SH-E1713-BH2018-07-16
20817583020905Critical Cover SH-E1715-BH SH-E1715-BH2018-07-16
20817583020912Critical Cover SH-E1716-BH SH-E1716-BH2018-07-16
20817583020929Critical Cover SH-E1W11-BH SH-E1W11-BH2018-07-16
20817583020936Critical Cover SH-E1W12-BH SH-E1W12-BH2018-07-16
20817583020943Critical Cover SH-E1W13-BH SH-E1W13-BH2018-07-16
20817583020950Critical Cover SH-E1W15-BH SH-E1W15-BH2018-07-16
20817583020974Critical Cover SH-G1253-B SH-G1253-B2018-07-16
20817583020981Critical Cover SH-H1253-B SH-H1253-B2018-07-16
20817583021001Critical Cover SH-M1312-BH SH-M1312-BH2018-07-16
20817583021018Critical Cover SH-M1313-BH SH-M1313-BH2018-07-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
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16980077680194AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680200AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
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16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
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16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19