FDA.reportPublic FDA data

Dental Mates

Primary DI
00860009046474
Brand
Dental Mates
Company
M.Y.T. USA Corp.
Model
Sterilization Pouches 3 1/2 x 6 1/2
Device description
Sterilization Pouches
Published
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193561000Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel PouchWeihai Xingtai Packaging Products Co., Ltd.2020-04-15FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009046474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009046474008600090464748600090464740860009046474

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118764392
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
00080169153595BORDOVAVINYL EXAM GLOVES SIZE LARGE2022-11-30
00840169153793Dental Mates"Sterilization Pouches 7 1/2 X 14"""2023-02-25
00840169153588BORDOVAVINYL EXAM GLOVES SIZE MEDIUM2022-11-30
00840169153601PLATINUMVINYL EXAM GLOVES SIZE MEDIUM2022-11-30
00840169153618PLATINUMVINYL EXAM GLOVES SIZE LARGE2022-11-30
00860009046467Dental MatesSterilization Pouches 2 1/4 x 52022-11-17
00860009046481Dental MatesSterilization Pouches 3 1/2 x 102022-11-17
00840169153540Dental MatesLATEX EXAM GLOVES SIZE SMALL2022-11-16
00840169153557Dental MatesLATEX EXAM GLOVES SIZE MEDIUM2022-11-16
00840169153564Dental MatesLATEX EXAM GLOVES SIZE LARGE2022-11-16
00840169153571Dental MatesLATEX EXAM GLOVES SIZE XL2022-11-16
00840169153533Dental MatesLATEX EXAM GLOVES XS2022-11-14
00860009046405Dental MatesSize XS2022-08-17
00860009046412Dental MatesSize Small2022-08-17
00860009046429Dental MatesSize Medium2022-08-17
00860009046436Dental MatesSize Large2022-08-17
00860009046443Dental MatesSize XL2022-08-17
00860009046450Dental MatesASTM LEVEL 3 MASK2022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456206881JMUJMU DENTAL, INCFRG2026-07-08
00840456206898JMUJMU DENTAL, INCFRG2026-07-08
00840456206928JMUJMU DENTAL, INCFRG2026-07-08
10686864061868MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061875MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061899MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061905MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061912MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
10686864061929MEDICOM SAFESEALAMD Medicom IncFRG2026-06-25
00850072625867Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
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00850088572049Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572056Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572063Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
00850088572070Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCFRG2026-06-22
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