Puregraft Injection Kit

GUDID 00850034511382

A kit containing cannulas, needles, and connectors for use by a physician.

Bimini Technologies LLC

General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00850034511382
• NIH Device Record Key: 9ef367e6-af92-4c82-b1fc-ae8eaec22ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puregraft Injection Kit
• Version Model Number: CANNULA-SET
• Company DUNS: 076649467
• Company Name: Bimini Technologies LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850034511375 [Primary]
GS1	00850034511382 [Package]; Contains: 00850034511375; Package: Box [5 Units]; In Commercial Distribution

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-27
• Device Publish Date: 2022-10-19

Devices Manufactured by Bimini Technologies LLC

• 00850034511993 - DIRECT2 Lid: 2024-10-14 This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade vacuum canister. The DIRECT2 connects an
• 00850034511009 - Puregraft 850 System Twin Pack: 2024-08-30 A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filteri
• 00850034511153 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511337 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511399 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511627 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511658 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant
• 00850034511672 - Puregraft Serene Breast Implant: 2024-04-05 Saline Breast Implant