METIS®

GUDID M248139107ND1

The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the implant.

NEWDEAL

Orthopaedic osteotome

• Primary Device ID: M248139107ND1
• NIH Device Record Key: ba256d20-0abb-476e-9b13-0ac4130eb8cc
• Commercial Distribution Discontinuation: 2024-02-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: METIS®
• Version Model Number: 139107ND
• Company DUNS: 536935331
• Company Name: NEWDEAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780051497 [Primary]
HIBCC	M248139107ND1 [Secondary]

FDA Product Code

• HWM: OSTEOTOME

Sterilization

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

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

[M248139107ND1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-07
• Device Publish Date: 2017-05-26

Devices Manufactured by NEWDEAL

• M248119510ND1 - I.CO.S®: 2025-04-28 The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed s
• M248119511ND1 - I.CO.S®: 2025-04-28 The measurer is used to measure the 250mm K-wire in place and decide the compression screw length to implant. It is placed so th
• M248119532ND1 - I.CO.S®: 2025-04-28 The cannulated graduated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to power implant the 4.0mm compre
• M248119536ND1 - I.CO.S®: 2025-04-28 The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i
• M248119562ND1 - I.CO.S®: 2025-04-28 The cannulated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to implant the 6.5mm compression screws. It
• M248119566ND1 - I.CO.S®: 2025-04-28 The cannulated external screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i
• 10381780045892 - IPP-ON: 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis
• 10381780045908 - IPP-ON: 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis