OBS HANDLE / Black BD2906-0

GUDID 04719873180493

Operated with the shaft for screw insertion and removal. Material: AL6061/SUS304

BOMEI CO., LTD.

Fixture/appliance dental drill bit, reusable

• Primary Device ID: 04719873180493
• NIH Device Record Key: 03aa6877-7399-4bc1-9f50-db0b9b8bb429
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OBS HANDLE / Black
• Version Model Number: BD2906-0
• Catalog Number: BD2906-0
• Company DUNS: 657693730
• Company Name: BOMEI CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04719873180493 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[04719873180493]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2018-02-12

Devices Manufactured by BOMEI CO., LTD.

• 04719873180493 - OBS HANDLE / Black: 2020-01-09Operated with the shaft for screw insertion and removal. Material: AL6061/SUS304
• 04719873180493 - OBS HANDLE / Black: 2020-01-09 Operated with the shaft for screw insertion and removal. Material: AL6061/SUS304
• 04719873180509 - OBS BLADE: 2020-01-09 Using special gripping feature to hold screws. Material: SUS304
• 04719873180028 - OBS Anchorage Screw: 2018-07-19 OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13)
• 04719873180035 - OBS Anchorage Screw: 2018-07-19 OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13)
• 04719873180042 - OBS Anchorage Screw: 2018-07-19 OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13)
• 04719873180059 - OBS Anchorage Screw: 2018-07-19 OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13)
• 04719873180066 - OBS Anchorage Screw: 2018-07-19 OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13)
• 04719873180073 - OBS Anchorage Screw: 2018-07-19 OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13)