FDA.reportPublic FDA data

Dental Syringe 85mm, for 2.2ml vial

Primary DI
05060212057518
Brand
Dental Syringe 85mm, for 2.2ml vial
Company
DTR MEDICAL LIMITED
Model
DGS2001
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
05060212057518PackageGS120In Commercial Distribution
05060212052117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060212057518050602120575185060212057518
05060212052117050602120521175060212052117

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
424066509
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
true
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
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerASN20182026-06-10
05060212050687Bruenings Tongue Depressor, 190mmBRU20012026-06-10
05060212051042Crocodile Scissors Straight, stainless steelCSS1001-S2026-06-10
05060212051059Crocodile Scissors Curved, stainless steelCSC1001-S2026-06-10
05060212051103Crile Artery Forceps, 145mm StraightCFS2001-D2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatCFC2001-D2026-06-10
05060212051196Adson Non-Toothed Forceps 120mmADS5001-S2026-06-10
05060212051202Adson Toothed Forceps 120mmATS5001-S2026-06-10
05060212051264College Dental Forceps 160mmCDF20012026-06-10
05060212051721Clamp Cover Red (Small) 50mmCCR20312026-06-10
05060212051738Clamp Cover White (Med) 120mmCCW20412026-06-10
05060212051745Clamp Cover Blue (Large) 120mmCCB20512026-06-10
05060212052094Tischler Cervical Biopsy PunchCBT10012026-06-10
05060212052100Baby Tischler Cervical Biopsy PunchCBT1001B2026-06-10
05060212052339Cusco Specula Metal SmallCMM200S2026-06-10
05060212052346Cusco Specula Metal MediumCMM200M2026-06-10
05060212052360Cusco Specula Metal LargeCMM200L2026-06-10
05060212052629Cawthorne Hook 1.5mm 90 degree blackCTH2901-D2026-06-10
05060212052636Cawthorne Straight Point blackCTP2001-D2026-06-10
05060212053466Barron Suction Handle (3Fg)BSH20032026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08800075607799OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614391OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614407OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614421OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075624994OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075607812OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626332OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626349OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075626356OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-23
08800075614360OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800075614414OSUNG MNDOSUNG MND Co., Ltd.EJI2024-02-22
08800053042093DENOPSDENTIS CO. ,LTDEJI2024-01-23
00840326421765AstekYoung Innovations, Inc.EJI2023-12-01
00840326421772AstekYoung Innovations, Inc.EJI2023-12-01
00840326421789AstekYoung Innovations, Inc.EJI2023-12-01