FLEXIBLE REAMER WITH Multiple Flute TIP, 15.5 MM

GUDID M209223990

BIOPRO, INC.

Bone-resection orthopaedic reamer, reusable

Primary Device ID	M209223990
NIH Device Record Key	cb76ccf3-7508-4c20-8b0b-35a07421d951
Commercial Distribution Status	In Commercial Distribution
Brand Name	FLEXIBLE REAMER WITH Multiple Flute TIP, 15.5 MM
Version Model Number	22399
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	true
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
HIBCC	M209223990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163627

FDA Product Code

Reamer

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

[M209223990]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2020-07-23
Device Publish Date	2019-06-12

Devices Manufactured by BIOPRO, INC.

M209177990 - THUMB MOD HEAD TITANIUM 13MM+2	2024-07-08
M209178000 - THUMB MOD HEAD TITANIIUM 12MM	2024-07-08
M209178010 - THUMB MOD HEAD TITANIUM 12MM+2	2024-07-08
M209178060 - THUMB MOD HEAD TITANIUM 14MM	2024-07-08
M209178070 - THUMB MOD HEAD TITANIUM 14MM+2	2024-07-08
M209178080 - THUMB MOD HEAD TITANIUM 15MM	2024-07-08
M209178090 - THUMB MOD HEAD TITANIUM 15MM+2	2024-07-08
M209177980 - THUMB MOD HEAD TITANIUM 13MM	2024-06-07

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