YomiLink Bone (UR)

GUDID 00810004900493

YomiLink Bone (UR)

NEOCIS INC

Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system Dental stereotactic surgery system 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

• 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)
• 00810004900493 - YomiLink Bone (UR): 2023-03-01YomiLink Bone (UR)
• 00810004900493 - YomiLink Bone (UR): 2023-03-01 YomiLink Bone (UR)
• 00810004900509 - YomiLink Bone (LL): 2023-03-01 YomiLink Bone (LL)
• 00810004900516 - YomiLink Bone (LR): 2023-03-01 YomiLink Bone (LR)