FDA.reportPublic FDA data

Nyclave Tubing 4" X 100'

Primary DI
20302731124104
Brand
Nyclave Tubing 4" X 100'
Company
YOUNG DENTAL MANUFACTURING I, LLC
Model
112410
Device description
Sterilization tubing
Published
2016-09-23
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

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
20302731124104PackageGS136In Commercial Distribution
10302731124107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2030273112410420302731124104
1030273112410710302731124107

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
006309355
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
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
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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

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Primary DI, Brand, Company table
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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
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