OBS Anchorage Screw BD-2016-0

GUDID 04719873180165

OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw wi

BOMEI CO., LTD.

Orthodontic anchoring screw

Primary Device ID	04719873180165
NIH Device Record Key	9f06f44d-0b5d-417c-ae26-31471452ce15
Commercial Distribution Status	In Commercial Distribution
Brand Name	OBS Anchorage Screw
Version Model Number	BD-2016-0
Catalog Number	BD-2016-0
Company DUNS	657693730
Company Name	BOMEI CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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	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	04719873180165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152297

FDA Product Code

OAT	Implant, Endosseous, Orthodontic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

[04719873180165]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2018-07-19
Device Publish Date	2016-09-01

On-Brand Devices [OBS Anchorage Screw]

04719873180585	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180479	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180462	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180455	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180448	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180431	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180424	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180400	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180394	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180387	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180370	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180363	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180356	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180349	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180325	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180318	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180301	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180295	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180288	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180271	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180264	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180240	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180233	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180226	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180219	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180202	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180196	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180189	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180165	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180158	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180141	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180134	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180127	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180110	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180103	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180080	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180073	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180066	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180059	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180042	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180035	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo
04719873180028	OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium allo

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