BioPro

GUDID M20922860

ONE PIECE THUMB STEM RASP 7.5MM

BIOPRO, INC.

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: M20922860
• NIH Device Record Key: a4aa3944-3b26-4d0c-a96b-e97c697ba31e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPro
• Version Model Number: 22860
• Company DUNS: 618749857
• Company Name: BIOPRO, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
HIBCC	M20922860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061089

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

[M20922860]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-07
• Device Publish Date: 2021-04-29

On-Brand Devices [BioPro]

• M20922798: Horizon Subtalar 8" Packaged Non Sterile
• M20922795: MVA Drill Guide 3.0-3.5mm Sterile
• M20920972: MVA Drill Guide 3.0-3.5mm Sterile
• M20920970: Locking Drill Guide Solid 3.5mm Sterile
• M20920969: Locking Drill Guide 3.5mm Sterile
• M20920968: Locking Drill Guide 3.0mm Sterile
• M20922864: THUMB RASP INSTRUMENT KIT
• M20922863: THUMB RASP INSTRUMENT TRAY
• M20922862: ONE PIECE THUMB STEM RASP 10.0MM
• M20922861: ONE PIECE THUMB STEM RASP 8.5MM
• M20922860: ONE PIECE THUMB STEM RASP 7.5MM
• M209229340: Osteotomy Plate Module
• M209229240: K-wire Sterile 1.6mmx150mm Double Trochar 5pack
• M209229220: K-wire Sterile 1.1mmx150mm Double Trochar 5pack
• M209229210: K-wire Sterile 0.9mmx150mm Double Trochar 5pack
• M209229200: K-wire Sterile 1.6mmx150mm Double Trochar
• M209229190: K-wire Sterile 1.1mmx150mm Double Trochar
• M209229180: K-wire Sterile 0.9x150mm Double Trochar
• M209229170: K-wire 1.6x150mm Double Trochar
• M209229160: K-wire 1.1x150mm Double Trochar
• M209229150: K-wire 0.9x150mm Double Trocar