SURGAIRTOME TWO 00505800100

GUDID 30845854018921

SURGAIRTOME TWO HANDPIECE

Conmed Corporation

Surgical power tool system handpiece, sawing, pneumatic Surgical power tool system handpiece, sawing, pneumatic

• Primary Device ID: 30845854018921
• NIH Device Record Key: 1958566f-29fd-482c-98a9-fb8b44e123ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGAIRTOME TWO
• Version Model Number: 00505800100
• Catalog Number: 00505800100
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	20845854018924 [Primary]
GS1	30845854018921 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K781979

FDA Product Code

• HSZ: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Sterilization

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

[30845854018921]

Moist Heat or Steam Sterilization

[30845854018921]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 10653405000020 - NA: 2024-06-06 ECG LEADWIRES
• 10653405004578 - NA: 2024-06-06 5-LEAD COMBINER
• 10653405004608 - NA: 2024-06-06 RE-ORDER TAG
• 10653405004622 - NA: 2024-06-06 ECG CABLES
• 10653405064220 - NA: 2024-06-06 ECG LEADWIRES
• 30845854080751 - PENADAPT: 2024-05-03 PenAdapt Electrosurgical Pencil Adapter 1 ft (30.5cm) tubing
• 30845854061767 - NA: 2024-05-03 EY Tubing Kit 1-3/8 in (35mm) x 6 ft (1.8m) tube and six 2 ft (.6m) tubes with integral wand & sponge guard
• 30845854045798 - CrossFT: 2024-04-26 CrossFT Knotless Biocomposite 4.0 mm Suture Anchor with one 2 mm Hi-Fi Tape (Blue)