FDA.reportPublic FDA data

Dental Syringe Long 115mm, for 2.2ml vial

Primary DI
05060212052124
Brand
Dental Syringe Long 115mm, for 2.2ml vial
Company
DTR MEDICAL LIMITED
Model
DGSL2001
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05060212057525PackageGS120In Commercial Distribution
05060212052124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060212057525050602120575255060212057525
05060212052124050602120521245060212052124

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.

Regulatory Flags#

DUNS number
424066509
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060212052162Sims Uterine SoundUSH20012024-10-14
05060411980471Aspiration Cannulae 70mm Angled, 1.4mm/17G74-1231A 2024-10-14
05060411980662Aspiration Cannulae 70mm Angled, 1.2mm/18G74-1232 2024-10-14
05060411980730Aspiration Cannulae 70mm Angled, 1.0mm/19G74-1232A 2024-10-14
05060411980747Aspiration Cannulae 70mm Angled, 0.9mm/20g74-1233 2024-10-14
05060411980792Aspiration Cannulae 70mm Angled, 0.7mm/22G74-1234 2024-10-14
05060411980853Aspiration Cannulae 70mm Angled, 0.55mm/24G74-1236 2024-10-14
05060411980860Aspiration Cannulae 80mm Angled, 2.0mm/14G74-1260 2024-10-14
05060411981218Aspiration Cannulae 80mm Angled, 1.0mm/19G74-1262A 2024-10-14
05060411981225Aspiration Cannulae 80mm Angled,1.4mm/17G74-1264 2024-10-14
05060411981232Aspiration Cannulae 70mm Angled, 1.6mm/16G74-12312024-10-14
05060411981249Aspiration Cannulae 80mm Angled, 1.7mm/15G74-12652024-10-14
05060411981256Aspiration Cannulae 80mm Angled, 2.5mm/13G74-1267 2024-10-14
05060411981263Aspiration Cannulae 80mm Angled, 3.0mm/11G74-12682024-10-14
05060411981270Aspiration Cannulae 100mm Angled, 3.0mm/11G74-1297 2024-10-14
05060411981386Brackmann type, 1.6mm x 115mm, 40 degree bend, suction control hole, open end74-2009 2024-10-14
05060411981560Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro74-2011 2024-10-14
05060411981577Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012 2024-10-14
05060411981799Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012P 2024-10-14
05060411981805Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control h74-2013 2024-10-14

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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
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
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08800075607799OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
08800075614391OSUNG MNDOSUNG MND Co., Ltd.EJI2024-03-05
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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