FDA.reportPublic FDA data

Young

Primary DI
10302731180158
Brand
Young
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
118015
Catalog number
118015
Device description
Young Nyclave EZ GUARD Sterilization 6 Inch X8 Inch Perforated Sheets
Published
2022-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization wrap containers, trays, cassettes & other accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10302731180158PackageGS11In Commercial Distribution
00302731180151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030273118015810302731180158
00302731180151003027311801513027311801510302731180151

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

Contacts#

Phone, Email table
PhoneEmail
+1(800) 325-1881customerservice@younginnovations.com

Regulatory Flags#

DUNS number
006309355
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00302730001723Young2962672962672026-05-15
00302730001730Young2962652962652026-05-15
10302732957827Varnish Pen - Assorted2957822017-07-17
10302730701309Varnish America 0.25ml Box / 200 White Bubblegum07-01302017-08-31
10302732958350Varnish Pen - Mint2958352017-07-17
10302732958367Varnish Pen - Assorted2958362017-07-17
00302730002508Zooby2962012962012022-10-16
10302733701016Etching Gel 5mL/20 Tips3701012016-09-23
10302733701047Etching Gel 5 mL/40 Tips3701042016-09-23
00302730003383Young Dental2969972025-09-05
00302732322253Young Dental2322252322252025-02-17
00302732342251Young Dental2342252342252025-02-17
10302732958305Barrier Sleeve, Young Infinity Cordless Handpiece, 25ct2958302018-05-25
10302732958312Barrier Sleeve, Young Infinity Cordless Handpiece, 500ct2958312018-05-25
10302736702508Short Pen Sleeve6702502017-10-27
10302736703505Light Handle Sleeve6703502017-10-27
10302736704502Low Speed Handpiece Sleeve6704502017-10-27
00302730002348Young2958302958302022-10-16
00302730002355Young2958312958312022-10-16
00302730002362Denticator6700506700502022-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522809X-PACEXPANDING INNOVATIONS, INC.KCT2026-05-27
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07640166769651Z5m(t)-neo Tray FullZ-Systems AGKCT2026-05-17
07640462720332NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720660NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720677NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07640462720684NUVENTUS NV.C™InfinetaMed AGKCT2026-05-13
07630031782298Straumann Modular CassetteInstitut Straumann AGKCT2026-05-07
10197344177806MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177813MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177820MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178117MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178124MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178285MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
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10197344178438MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178469MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178476MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178490MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178506MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178513MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178568MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178629MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178650MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178667MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344178698MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-23
10197344177783MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177790MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177950MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15
10197344177967MEDLINEMEDLINE INDUSTRIES, INC.KCT2026-04-15