FDA.reportPublic FDA data

TUTEM

Primary DI
00817583020390
Brand
TUTEM
Company
Alpha Pro Tech, Inc.
Model
6055-5 COLD COUTURE
Catalog number
6055-5 COLD COUTURE
Device description
EARLOOP, TUTEM-COLD COUTURE.
Published
2016-11-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
10817583020397PackageGS13000Not in Commercial Distribution
00817583020390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081758302039710817583020397
00817583020390008175830203908175830203900817583020390

GMDN Terms#

Term, Definition table
TermDefinition
Surgical hoodA non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
102710720
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817583020342Critical CoverSH-12524-BSH-12524-B2026-04-16
10817583020731Critical Cover SH-12522-B SH-12522-B2018-07-16
10817583020748Critical Cover SH-12523-B SH-12523-B2018-07-16
10817583020304Critical CoverGR5005GR50052016-11-03
10817583020311Critical CoverPK5005PK50052016-11-03
10817583020335Critical CoverBL5100BL51002016-11-03
10817583020564Critical CoverBL5500BL55002016-11-03
10817583020625Critical Cover1008 Biotrol1008 Biotrol2016-11-03
00817583020635Critical Cover1008 COTT BULK1008 COTT BULK2016-11-03
00817583020642Critical Cover1015 COTT BULK1015 COTT BULK2016-11-03
10817583020236Critical CoverGR6055GR60552016-11-03
10817583020137Critical Cover695CRX695CRX2016-11-03
10817583020243Critical CoverPK6055PK60552016-11-03
10817583020250Critical CoverYL6055YL60552016-11-03
10817583020595Critical CoverBL6155BENBL6155BEN2016-11-15
10817583020601Critcal CoverPK6155-BENPK6155-BEN2016-11-15
10817583020618Critical CoverWH6155BENWH6155BEN2016-11-15
10817583020687Critical Cover MS-01J76-4ST MS-01J76-4ST2018-07-16
10817583020694Critical Cover MS-01J76-8ST MS-01J76-8ST2018-07-16
10817583023329Critical Cover9400 Veil9400 Veil2020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850056441261Target Up&UpTARGET CORPORATIONFXX2026-06-25
00850056441254Target Up&UpTARGET CORPORATIONFXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05