Neobiotech Implant System

GUDID 08809486296721

Ø3.2*15.0mm

Neobiotech. co., ltd

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• Primary Device ID: 08809486296721
• NIH Device Record Key: cc70d918-1abc-4131-8843-5b8cee97b70f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neobiotech Implant System
• Version Model Number: IS3SN3015AP
• Company DUNS: 688371566
• Company Name: Neobiotech. 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: 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	08809486296721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190849

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: 2019-11-08
• Device Publish Date: 2019-10-31

On-Brand Devices [Neobiotech Implant System]

• 08809407155304: Ø4.5*5mm
• 08809407155298: Ø4.5*4mm
• 08809407155281: Ø4.5*3mm
• 08809407155243: Ø4.0*4mm
• 08809407155236: Ø4.0*3mm
• 08809407155229: Ø4.0*2mm
• 08809276760531: Ø4.5*2mm, L:6mm
• 08809486290347: Ø4.8*5.8mm
• 08809486293782: Ø3.6*6.4mm
• 08809486293775: Ø3.45*5.85mm
• 08809486292723: Ø5.5*2.8mm
• 08809486290460: Ø5.5*3.8mm
• 08809486290361: Ø5.5*5.8mm
• 08809486290354: Ø5.5*4.8mm
• 08809486290330: Ø4.8*4.8mm
• 08809486290255: Ø5.5*7.8mm
• 08809486290248: Ø5.5*6.8mm
• 08809486290217: Ø4.8*7mm
• 08809486290200: Ø4.8*6.8mm
• 08809486290170: Ø4.8*3.8mm
• 08809486290163: Ø4.8*2mm
• 08809407157056: ø3.0*8.5mm
• 08809407154475: Ø9.0*4.8mm
• 08809407154468: Ø9.0*3.8mm
• 08809407154451: Ø9.0*2.8mm
• 08809407154413: Ø8.0*4.8mm
• 08809407154406: Ø8.0*3.8mm
• 08809407154390: Ø8.0*2.8mm
• 08809407154383: Ø6.8*7.8mm
• 08809407154376: Ø6.8*6.8mm
• 08809407154369: Ø6.8*5.8mm
• 08809407154352: Ø6.8*4.8mm
• 08809407154345: Ø6.8*3.8mm
• 08809407154338: Ø6.8*2.8mm
• 08809407154321: Ø6.0*7.8mm
• 08809407154314: Ø6.0*6.8mm
• 08809407154307: Ø6.0*5.8mm
• 08809407154291: Ø6.0*4.8mm
• 08809407154284: Ø6.0*3.8mm
• 08809407154277: Ø6.0*2.8mm
• 08809407151351: Ø6.5*5mm, L:6.5mm
• 08809407151245: Ø6.5*2mm, L:4.0mm
• 08809407150491: Ø4.5*4mm, L:7.0mm
• 08809276764294: Ø7.0*13.0mm
• 08809276764270: Ø7.0*11.5mm
• 08809276764256: Ø7.0*10.0mm
• 08809276764232: Ø7.0*8.5mm
• 08809276764218: Ø7.0*7.3mm
• 08809276764195: Ø6.0*13.0mm
• 08809276764171: Ø6.0*11.5mm