Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm

GUDID 08800052607361

Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm

SHINA MED CORPORATION

Insulin syringe/needle, basic

• Primary Device ID: 08800052607361
• NIH Device Record Key: 08fe86e4-6d32-433c-aa68-bf0d1253f9e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm
• Version Model Number: SFI12811
• Company DUNS: 689061990
• Company Name: SHINA MED CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800052607361 [Package]; Contains: 08800052607903; Package: Box [100 Units]; In Commercial Distribution
GS1	08800052607378 [Package]; Package: Case [5 Units]; In Commercial Distribution
GS1	08800052607385 [Package]; Contains: 08800052607378; Package: Master Case [6 Units]; In Commercial Distribution
GS1	08800052607903 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210848

FDA Product Code

• FMF: Syringe, Piston

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

[08800052607361]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-15
• Device Publish Date: 2023-11-07

Devices Manufactured by SHINA MED CORPORATION

• 08800052607361 - Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm: 2023-11-15Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm
• 08800052607361 - Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm: 2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 28G 12.7mm
• 08800052607392 - Sure Fine™ Insulin Syringes 1.0cc 30G 8mm: 2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 30G 8mm
• 08800052607422 - Sure Fine™ Insulin Syringes 1.0cc 30G 12.7mm: 2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 30G 12.7mm
• 08800052607453 - Sure Fine™ Insulin Syringes 1.0cc 31G 8mm: 2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 31G 8mm
• 08800052607484 - Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm: 2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 29G 12.7mm
• 08800052607514 - Sure Fine™ Insulin Syringes 1.0cc 31G 6mm: 2023-11-15 Sure Fine™ Insulin Syringes 1.0cc 31G 6mm
• 08800052607545 - Sure Fine™ Insulin Syringes 0.5cc 30G 8mm: 2023-11-15 Sure Fine™ Insulin Syringes 0.5cc 30G 8mm
• 08800052607576 - Sure Fine™ Insulin Syringes 0.5cc 30G 12.7mm: 2023-11-15 Sure Fine™ Insulin Syringes 0.5cc 30G 12.7mm