MENIX MEN9000402

GUDID 03760304680731

MENIX Twister to be used with MENIX and MENIX DUO devices in meniscal repair.

S.B.M

Manual orthopaedic bender, reusable

• Primary Device ID: 03760304680731
• NIH Device Record Key: 226d45fa-67b4-4250-b2ab-8f30376c02cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MENIX
• Version Model Number: MENIX Twister
• Catalog Number: MEN9000402
• Company DUNS: 772462123
• Company Name: S.B.M
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760304680731 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

[03760304680731]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-03
• Device Publish Date: 2023-09-25

On-Brand Devices [MENIX]

• 03760304680533: MENIX® system consists of a single-use launcher which deploys a nonabsorbable implant composed
• 03760304680779: MENIX Arthroscopic scissors to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680762: MENIX rasp to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680755: MENIX 90 degree probe to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680748: MENIX Knot pusher to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680731: MENIX Twister to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680557: MENIX Suture cutter to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680540: MENIX Portal skid to be used with MENIX and MENIX DUO devices in meniscal repair.
• 03760304680816: Complete instrumentation set intended to be used for arthroscopic meniscus repair.