AnyOne Onestage Fixture OSF3510LH

GUDID 08806388246946

Ø3.5/ L=10/ C=2.2

Megagen Implant Co. Ltd

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• Primary Device ID: 08806388246946
• NIH Device Record Key: 0ecc90aa-9006-46e9-a36f-f46ec5ee6db9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyOne Onestage Fixture
• Version Model Number: OSF3510L
• Catalog Number: OSF3510LH
• Company DUNS: 687388178
• Company Name: Megagen Implant Co. Ltd
• 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: true
• Manufacturing Date: true
• 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	08806388246946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210161

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [AnyOne Onestage Fixture]

• 08806388270989: Ø5/ L=15/ C=1.2
• 08806388270972: Ø5/ L=13/ C=1.2
• 08806388270965: Ø5/ L=11.5/ C=1.2
• 08806388270958: Ø5/ L=10/ C=1.2
• 08806388270941: Ø5/ L=8.5/ C=1.2
• 08806388270934: Ø5/ L=7/ C=1.2
• 08806388270927: Ø4.5/ L=15/ C=1.2
• 08806388270910: Ø4.5/ L=13/ C=1.2
• 08806388270903: Ø4.5/ L=11.5/ C=1.2
• 08806388270897: Ø4.5/ L=10/ C=1.2
• 08806388270880: Ø4.5/ L=8.5/ C=1.2
• 08806388270873: Ø4.5/ L=7/ C=1.2
• 08806388246830: Ø4.5/ L=11.5/ C=1.8
• 08806388246823: Ø4.5/ L=10/ C=1.8
• 08806388246816: Ø4.5/ L=8.5/ C=1.8
• 08806388273492: Ø4.5/ L=7/ C=2.2
• 08806388273010: Ø4/ L=8.5/ C=2.2
• 08806388273003: Ø4/ L=7/ C=2.2
• 08806388247271: Ø5/ L=15/ C=2.2
• 08806388247264: Ø5/ L=13/ C=2.2
• 08806388247257: Ø5/ L=11.5/ C=2.2
• 08806388247240: Ø5/ L=10/ C=2.2
• 08806388247233: Ø5/ L=8.5/ C=2.2
• 08806388247226: Ø5/ L=7/ C=2.2
• 08806388247219: Ø4.5/ L=15/ C=2.2
• 08806388247202: Ø4.5/ L=13/ C=2.2
• 08806388247196: Ø4.5/ L=11.5/ C=2.2
• 08806388247189: Ø4.5/ L=10/ C=2.2
• 08806388247172: Ø4.5/ L=8.5/ C=2.2
• 08806388247165: Ø4.5/ L=7/ C=2.2
• 08806388246915: Ø5/ L=15/ C=1.8
• 08806388246908: Ø5/ L=13/ C=1.8
• 08806388246892: Ø5/ L=11.5/ C=1.8
• 08806388246885: Ø5/ L=10/ C=1.8
• 08806388246878: Ø5/ L=8.5/ C=1.8
• 08806388246861: Ø5/ L=7/ C=1.8
• 08806388246854: Ø4.5/ L=15/ C=1.8
• 08806388246847: Ø4.5/ L=13/ C=1.8
• 08806388246809: Ø4.5/ L=7/ C=1.8
• 08806388246762: Ø5/ L=10/ C=1.8
• 08806388273072: Ø5/ L=10/ C=2.2
• 08806388273065: Ø5/ L=8.5/ C=2.2
• 08806388273058: Ø5/ L=7/ C=2.2
• 08806388273041: Ø4.5/ L=10/ C=2.2
• 08806388273034: Ø4.5/ L=8.5/ C=2.2
• 08806388273027: Ø4/ L=10/ C=2.2
• 08806388270866: Ø5/ L=15/ C=1.2
• 08806388270859: Ø5/ L=13/ C=1.2
• 08806388270842: Ø5/ L=11.5/ C=1.2
• 08806388270835: Ø5/ L=10/ C=1.2