Agee TurnKey FCS®

GUDID 00861994000229

Orthopaedic bone pin, non-bioabsorbable

Primary Device ID	00861994000229
NIH Device Record Key	e803dfba-7b36-4f78-8a55-890f3e1e402b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Agee TurnKey FCS®
Version Model Number	FCS-400
Company DUNS	620754127
Company Name	Hand Biomechanics Lab 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	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00861994000229 [Primary]

JEC	Component, Traction, Invasive

Steralize Prior To Use	false
Device Is Sterile	true

00861994000281 - Disposable Blade Assembly	2021-12-14 Endoscopic Carpal Tunnel Release Disposable Blade Assembly
00861994000243 - PIP Fix	2019-03-11 External fixation system for dorsal fracture dislocations of the PIP joint.
00861994000205 - Agee WristJack®	2018-07-06 Fracture Reduction System. Fracture reduction and external fixation for treatment of distal radius fractures.
00861994000212 - Agee Digit Widget®	2018-07-06 External fixation system for treatment of PIP joint flexion contractures.
00861994000229 - Agee TurnKey FCS®	2018-07-06External fixation system for acute dorsal fracture dislocations of the PIP joint.
00861994000229 - Agee TurnKey FCS®	2018-07-06 External fixation system for acute dorsal fracture dislocations of the PIP joint.
00861994000236 - Agee WristJack® Remanufactured	2018-07-06 Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fract