FDA.reportPublic FDA data

1ml Tuberculin Suresafe Syringe

Primary DI
05391530750233
Brand
1ml Tuberculin Suresafe Syringe
Company
DMC MEDICAL LIMITED
Model
1ml Tuberculin Syringe - 25G x 5/8"
Catalog number
FD-SSFX01T-25
Device description
1ml Tuberculin Automatic Retraction Safety Syringe - 25G x 5/8" - Sterile
Published
2016-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141349000Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd.2015-04-10MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391530750226PackageGS1100In Commercial Distribution
05391530750233PackageGS121In Commercial Distribution
05391530750219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391530750226053915307502265391530750226
05391530750233053915307502335391530750233
05391530750219053915307502195391530750219

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
989772017
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
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
05391530754941NuGen syringeFD-1180NS 3ml Nugen Syringe - Red PlungerFD-1180NS 3ml Nugen Syringe - Red Plunger2026-06-03
05391530754965NuGen syringeFD-1162NS 10ml Nugen Syringe - Red PlungerFD-1162NS 10ml Nugen Syringe - Red Plunger2026-06-03
05391530753814NuGen syringeFD-1036NS - 30ml PC Syringe - Blue PlungerFD-1036NS - 30ml PC Syringe - Blue Plunger2026-06-01
05391530753876NuGen syringeFD-1159NS - 1ml Nugen Syringe - White PlungerFD-1159NS - 1ml Nugen Syringe - White Plunger2026-06-01
05391530753890NuGen syringeFD-1172NS - 1ml Nugen Syringe - Blue PlungerFD-1172NS - 1ml Nugen Syringe - Blue Plunger2026-06-01
05391530753913NuGen syringeFD-1165NS - 10ml Nugen Syringe - Purple PlungerFD-1165NS - 10ml Nugen Syringe - Purple Plunger2026-06-01
05391530753852NuGen syringeFD-1167NS 3ml Nugen Syringe - Blue PlungerFD-1167NS 3ml Nugen Syringe - Blue Plunger2026-05-31
05391530753944Polycarbonate syringeFD-1017NS -1ml PC Syringe White PlungerFD-1017NS -1ml PC Syringe White Plunger2026-06-03
05391530753951Polycarbonate syringeFD-1018NS - 1ml PC Syringe - Blue SyringeFD-1018NS - 1ml PC Syringe - Blue Syringe2026-06-03
05391530754217Polycarbonate syringeFD-1078NS 20ml PC Syringe - White Plunger - SalineFD-1078NS 20ml PC Syringe - White Plunger - Saline2026-06-03
05391530754620Polycarbonate syringeFD-1048NS 10ml PC Syringe Yellow PlungerFD-1048NS 10ml PC Syringe Yellow Plunger2026-06-03
05391530754699Polycarbonate syringeFD-1075NS 10ml PC Syringe - Light Blue Plunger XylFD-1075NS 10ml PC Syringe - Light Blue Plunger Xyl2026-06-03
05391530753968Polycarbonate syringeFD-1019NS - 1ml PC Syringe - Yellow PlungerFD-1019NS - 1ml PC Syringe - Yellow Plunger2026-06-02
05391530754088Polycarbonate syringeFD-1021NS 3ml PC Syringe - White PlungerFD-1021NS 3ml PC Syringe - White Plunger2026-06-02
05391530754194Polycarbonate syringeFD-1034NS 20ml PC Syringe - Red PlungerFD-1034NS 20ml PC Syringe - Red Plunger2026-06-02
05391530754224Polycarbonate syringeFD-1033NS 20ml PC SyringeFD-1033NS 20ml PC Syringe2026-06-02
05391530754231Polycarbonate syringeFD-1092NS 20ml PC Syringe Heparin Print - Red PlunFD-1092NS 20ml PC Syringe Heparin Print - Red Plun2026-06-02
05391530753456Polycarbonate syringeFD-1032NS - 20ml PC Syringe Blue PlungerFD-1032NS - 20ml PC Syringe Blue Plunger2026-06-01
05391530753463Polycarbonate syringeFD-1031NS - White PlungerFD-1031NS - 20ml PC Syringe White Plunger2026-06-01
05391530753487Polycarbonate syringeFD-1113NS - 10ml PC Syringe Contrast Dark Green PlFD-1113NS - 10ml PC Syringe Contrast Dark Green Pl2026-06-01

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