YomiLink Bone (UR)

GUDID 00810004900493

YomiLink Bone (UR)

NEOCIS INC

Dental stereotactic surgery system

• Primary Device ID: 00810004900493
• NIH Device Record Key: 923afd23-ba50-44ec-a7e2-8845b64debf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YomiLink Bone (UR)
• Version Model Number: DRW-1356-02
• Company DUNS: 802312434
• Company Name: NEOCIS INC
• 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: false
• Manufacturing Date: false
• 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	00810004900493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222750

FDA Product Code

• PLV: Dental Stereotaxic Instrument

Sterilization

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

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

[00810004900493]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-01
• Device Publish Date: 2023-02-21

Devices Manufactured by NEOCIS INC

• 00810004900394 - Neocis Guidance System: 2024-07-29 TrackerNeo Draping Kit
• 00810004900608 - YomiLink Teeth Posterior (LRUL): 2024-05-27 YomiLink Teeth Posterior (LRUL)
• 00810004900615 - YomiLink Teeth Posterior (LLUR): 2024-05-27 YomiLink Teeth Posterior (LLUR)
• 00810004900523 - YomiLink Arch (LLUR): 2023-08-24 YomiLink Arch (LLUR)
• 00810004900530 - YomiLink Arch (LRUL): 2023-08-24 YomiLink Arch (LRUL)
• 00810004900547 - YLA Probing Bit - Contra Angle: 2023-08-24 YLA Probing Bit - Contra Angle
• 00810004900554 - YLA Probing Bit - Straight: 2023-08-24 YLA Probing Bit - Straight
• 00810004900486 - YomiLink Bone (UL): 2023-03-01 YomiLink Bone (UL)