Sure Fine™ Insulin Syringes 0.3cc 30G 12.7mm

GUDID 08800052607729

Sure Fine™ Insulin Syringes 0.3cc 30G 12.7mm

SHINA MED CORPORATION

Insulin syringe/needle, basic
Primary Device ID08800052607729
NIH Device Record Key18953b77-ec5d-4cad-8d09-8ef4683c48eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSure Fine™ Insulin Syringes 0.3cc 30G 12.7mm
Version Model NumberSFI33011
Company DUNS689061990
Company NameSHINA MED CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800052607729 [Package]
Contains: 08800052608023
Package: Box [100 Units]
In Commercial Distribution
GS108800052607736 [Package]
Package: Case [5 Units]
In Commercial Distribution
GS108800052607743 [Package]
Contains: 08800052607736
Package: Master Case [6 Units]
In Commercial Distribution
GS108800052608023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


[08800052607729]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-15
Device Publish Date2023-11-07

Devices Manufactured by SHINA MED CORPORATION

08800052607361 - Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm
08800052607392 - Sure Fine™ Insulin Syringes 1.0cc 30G 8mm2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 30G 8mm
08800052607422 - Sure Fine™ Insulin Syringes 1.0cc 30G 12.7mm2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 30G 12.7mm
08800052607453 - Sure Fine™ Insulin Syringes 1.0cc 31G 8mm2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 31G 8mm
08800052607484 - Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm
08800052607514 - Sure Fine™ Insulin Syringes 1.0cc 31G 6mm2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 31G 6mm
08800052607545 - Sure Fine™ Insulin Syringes 0.5cc 30G 8mm2023-11-15 Sure Fine™ Insulin Syringes 0.5cc 30G 8mm
08800052607576 - Sure Fine™ Insulin Syringes 0.5cc 30G 12.7mm2023-11-15 Sure Fine™ Insulin Syringes 0.5cc 30G 12.7mm

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