FDA.reportPublic FDA data

Astek

Primary DI
00840326421789
Brand
Astek
Company
Young Innovations, Inc.
Model
23003ASTEK
Catalog number
23003ASTEK
Device description
inSafe Syringe, 1.8ml, Harpoon Asp., Thumb Ring ? Astek
Published
2023-12-01
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
EJISyringe, cartridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJISyringe, CartridgeDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840326421786PackageGS11Not in Commercial Distribution
20840326421783PackageGS11Not in Commercial Distribution
00840326421789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084032642178610840326421786
2084032642178320840326421783
00840326421789008403264217898403264217890840326421789

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia injection kitA collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800) 558-6684support@youngspecialties.com

Regulatory Flags#

DUNS number
004193103
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843471120460DefendVP-8104VP-81042022-10-30
00843471120477DefendVP-8104TVP-8104T2022-10-30
00843471120484DefendVP-8105VP-81052022-10-30
00843471120491DefendVP-8105TVP-8105T2022-10-30
00843471120514DefendVP-8106VP-81062022-10-30
00843471120521DefendVP-8106TVP-8106T2022-10-30
00843471120538DefendVP-8107VP-81072022-10-30
00843471120545DefendVP-8108VP-81082022-10-30
00843471120552DefendVP-8108TVP-8108T2022-10-30
00843471120569DefendVP-8111VP-81112022-10-30
00843471120576DefendVP-8111TVP-8111T2022-10-30
00843471120583DefendVP-8140VP-81402022-10-30
00843471120590DefendVP-8140TVP-8140T2022-10-30
00843471120606DefendVP-8150TVP-8150T2022-10-30
00843471120637DefendVP-8165TVP-8165T2022-10-30
00843471143926Defend2926272926272022-10-30
00843471152782DefendCS-0100CS-01002022-10-30
00840326426630Astek1002991002992026-05-11
00840326423851Astek19025190252025-03-17
00840326423868Astek19026190262025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791002840DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791002970DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100297A0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100297B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100297C0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791003020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100302B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G8791003130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G879100313B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
G87910032910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJI2026-08-15
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEJI2025-12-22
00840326422670AstekYoung Innovations, Inc.EJI2025-10-10
00840326423691AstekYoung Innovations, Inc.EJI2025-10-10
00840326422687AstekYoung Innovations, Inc.EJI2025-05-27
00840326423707AstekYoung Innovations, Inc.EJI2025-05-27
00840326422663AstekYoung Innovations, Inc.EJI2025-05-27
00840326423684AstekYoung Innovations, Inc.EJI2025-05-27
00840326423721AstekYoung Innovations, Inc.EJI2025-05-27
05713513001185ASPIJECT Active CompactRønvig Dental Manufacturing A/SEJI2025-02-27
05060212052117Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212052124Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057518Dental Syringe 85mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
05060212057525Dental Syringe Long 115mm, for 2.2ml vialDTR MEDICAL LIMITEDEJI2024-10-11
00813677022882PDT, Inc.PDT, INC.EJI2024-07-01
00813677022905PDT, Inc.PDT, INC.EJI2024-07-01
00813677022899PDT, Inc.PDT, INC.EJI2024-06-27
08800075614360OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800075614414OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01
00840326421772AstekYoung Innovations, Inc.EJI2023-12-01