Agee WristJack® Remanufactured CFD-147-R

GUDID 00861994000236

Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fractures.

Hand Biomechanics Lab Inc

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00861994000236
NIH Device Record Key2f10aca4-0763-4155-b009-2db969729363
Commercial Distribution StatusIn Commercial Distribution
Brand NameAgee WristJack® Remanufactured
Version Model NumberCFD-147-RNS
Catalog NumberCFD-147-R
Company DUNS620754127
Company NameHand Biomechanics Lab Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com
Phone800-522-5778
Emailinfo@handbiolab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861994000236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JECComponent, Traction, Invasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

[00861994000236]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

Devices Manufactured by Hand Biomechanics Lab Inc

00861994000281 - Disposable Blade Assembly2021-12-14 Endoscopic Carpal Tunnel Release Disposable Blade Assembly
00861994000243 - PIP Fix2019-03-11 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®2018-07-06 External fixation system for acute dorsal fracture dislocations of the PIP joint.
00861994000236 - Agee WristJack® Remanufactured2018-07-06Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fractures.
00861994000236 - Agee WristJack® Remanufactured2018-07-06 Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fract
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