FDA.reportPublic FDA data

Dental Mates

Primary DI
00840169153793
Brand
Dental Mates
Company
M.Y.T. USA Corp.
Model
"Sterilization Pouches 7 1/2 X 14"""
Device description
Sterilization Pouches
Published
2023-02-25
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
00840169153793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840169153793008401691537938401691537930840169153793

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
Serial number
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
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
00860009046474Dental MatesSterilization Pouches 3 1/2 x 6 1/22022-11-17
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
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013645PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013652PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013669PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013676PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013683PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014888PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014895PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014901PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014918PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014970PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014987PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014994PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015007PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015014PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015021PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015038PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015045PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015052PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015069PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015076PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015083PRIMEDpriMED Medical Products IncFRG2026-06-04