SAFETY SYRINGES, 1cc 25G x 1"

GUDID 08800117112519

1cc 25G x 1"

Shina Corporation

Insulin syringe/needle, basic

• Primary Device ID: 08800117112519
• NIH Device Record Key: 08cf817c-9d8e-47d7-86c5-3a9afe5d6063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFETY SYRINGES, 1cc 25G x 1"
• Version Model Number: 1251
• Company DUNS: 688441448
• Company Name: Shina 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: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800117112519 [Primary]
GS1	18800117112516 [Package]; Package: Carton [100 Units]; In Commercial Distribution
GS1	28800117112513 [Package]; Contains: 18800117112516; Package: Case [500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080600

FDA Product Code

• MEG: Syringe, Antistick

Sterilization

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

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

[08800117112519]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-09
• Device Publish Date: 2021-03-01

Devices Manufactured by Shina Corporation

• 08800117132135 - SHINA: 2021-04-08 Luer Lock Safety Syringe with Needle 3mL, 21g x 1.5"
• 08800117132210 - SHINA: 2021-04-08 Luer Lock Safety Syringe with Needle 3mL, 22g x 1"
• 08800117132234 - SHINA: 2021-04-08 Luer Lock Safety Syringe with Needle 3mL, 22g x 1.5"
• 08800117132319 - SHINA: 2021-04-08 Luer Lock Safety Syringe with Needle 3mL, 23g x 1"
• 08800117132517 - SHINA: 2021-04-08 Luer Lock Safety Syringe with Needle 3mL, 25g x 1"
• 08800117132586 - SHINA: 2021-04-08 Luer Lock Safety Syringe with Needle 3mL, 25g x 5/8"
• 08800117112519 - SAFETY SYRINGES, 1cc 25G x 1": 2021-03-091cc 25G x 1"
• 08800117112519 - SAFETY SYRINGES, 1cc 25G x 1": 2021-03-09 1cc 25G x 1"
• 08800117112588 - SAFETY SYRINGES, 1cc 25G x 5/8": 2021-03-09 1cc 25G x 5/8"