FDA.reportPublic FDA data

UNOLOK

Primary DI
18903347051898
Brand
UNOLOK
Company
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
Model
3ml (22G x 1 1/2'')
Catalog number
05189
Device description
UNOLOK Single Use Hypodermic Syringe Luer Lock , 3ml with 22G x 1 1/2'' (0.70 X 38mm) Needle, Blister Packed
Published
2024-06-25
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945225000DISPOSABLE SYRINGES AND DISPOSABLE NEEDLESMyco Medical Supplies, Inc.1995-01-26FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18903347051898PackageGS1100In Commercial Distribution
28903347051895PackageGS120In Commercial Distribution
58903347051896PackageGS19In Commercial Distribution
08903347051891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890334705189818903347051898
2890334705189528903347051895
5890334705189658903347051896
08903347051891089033470518918903347051891

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA 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 non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe 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
862318107
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08903347051891UNOLOK3ml (22G x 1 1/2'')051892024-06-25
08903347023461Vaku-8"23 G X ¾"""023462017-01-09
08903347023478Vaku-8"25 G X ¾"""023472017-01-09
08903347002336UNOLOK+"19 G X ¾"""002332017-04-26
08903347002343UNOLOK+ "21 G X ¾"""002342017-04-26
08903347002350UNOLOK+ "23G X ¾"""002352017-04-26
08903347002367UNOLOK+ "25G X ¾"""002362017-04-26
08903347003241UNOLOK"19 G X ¾"""003242017-04-26
08903347003265UNOLOK "21 G X ¾"""003262017-04-26
08903347003272UNOLOK"22G X ¾"""003272017-04-26
08903347003289Unolok"23 G X ¾"""003282017-01-09
08903347003302Unolok"25 G X ¾"""003302017-01-09
08903347023423VAKU-8+ "21 G X ¾"""023422017-04-26
08903347023430VAKU-8+ "23G X ¾"""023432017-04-26
08903347023447VAKU-8+ "25G X ¾"""023442017-04-26
08903347023454Vaku-8"21 G X ¾"""023452017-01-09
08903347034696VAKU-8 "22G X 3/4"""034692017-04-26
18903347023468Vaku-823 G X ¾"023462017-01-09
18903347023475Vaku-825 G X ¾"023472017-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754057Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754118Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754149polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14