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

• M248PANTAXLSET1 - PANTA XL: 2024-08-23 The PANTA XL nail set inclides instrumentation wich are used as a guide for the implantation of PANTA XL Nail system.The PANTA X
• 10381780125891 - PANTA: 2024-08-23 The complete PANTA removal set includes instruments to be used for the removal of all PANTA nail system.
• 10381780064381 - B-BOP: 2024-07-11 In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a gr
• M248119580ND1 - I.CO.S®: 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h
• M248119590ND1 - I.CO.S®: 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h
• M248139107ND1 - METIS®: 2024-02-07The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the implant.
• M248139107ND1 - METIS®: 2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im
• M248529061ND1 - SURFIX®: 2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws.
• 10381780043317 - BASAL DORSAL PLATE: 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is