Easy Glide INSULIN SYRIN 0.5 ML 31GX5/16"

GUDID B2086315653

Easy Glide INSULIN SYRIN 0.5 ML 31GX5/16"

GLOBAL DIABETIC DISTRIBUTORS INC

Insulin syringe/needle, basic Insulin syringe/needle, basic

• Primary Device ID: B2086315653
• NIH Device Record Key: 2acf6072-a177-42a6-9fe2-b527efd54b49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Glide INSULIN SYRIN 0.5 ML 31GX5/16"
• Version Model Number: 631565
• Company DUNS: 796779283
• Company Name: GLOBAL DIABETIC DISTRIBUTORS INC
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2086315650 [Primary]
HIBCC	B2086315651 [Package]; Contains: B2086315650; Package: Box [5 Units]; In Commercial Distribution
HIBCC	B2086315652 [Package]; Contains: B2086315651; Package: Inner Case [5 Units]; In Commercial Distribution
HIBCC	B2086315653 [Package]; Contains: B2086315652; Package: Shipping Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110421

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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