FDA.reportPublic FDA data

Gemtier

Primary DI
06955356111471
Brand
Gemtier
Company
GEMTIER MEDICAL (SHANGHAI) INC.
Model
SY012525
Device description
"Sterile Syringe with Safety Needle for Single Use, 1ml syringe, 25G x 1""(0,5 x 25mm)"
Published
2021-03-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
FMINeedle, Hypodermic, Single LumenGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192679000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192679000Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single UseGemtier Medical (Shanghai), Inc.2020-04-10MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16955356111478PackageGS1100In Commercial Distribution
26955356111475PackageGS112In Commercial Distribution
06955356111471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695535611147816955356111478
2695535611147526955356111475
06955356111471069553561114716955356111471

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.

Contacts#

Phone, Email table
PhoneEmail
+862167360886sales@gemtier.com

Regulatory Flags#

DUNS number
529511052
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955356111440GemtierSY012525SY0125252021-03-15
16955356111478GemtierSY0125252021-03-22
16955356111447GemtierSY012525SY0125252021-03-15

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Primary DI, Brand, Company table
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