Disposable Blade Assembly CTR-455

GUDID 00861994000281

Endoscopic Carpal Tunnel Release Disposable Blade Assembly

Hand Biomechanics Lab Inc

Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Carpal tunnel release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument Hand ligament surgical release instrument
Primary Device ID00861994000281
NIH Device Record Keyd0d2f3a3-5560-49ee-aab8-cf3fcb166368
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Blade Assembly
Version Model NumberCTR-455
Catalog NumberCTR-455
Company DUNS620754127
Company NameHand Biomechanics Lab Inc
Device Count6
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com
Phone916-923-5073
Emailinfo@handbiolab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100861994000281 [Unit of Use]
GS110861994000288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMFKnife, Surgical
HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-14
Device Publish Date2021-12-06

Devices Manufactured by Hand Biomechanics Lab Inc

00861994000281 - Disposable Blade Assembly2021-12-14Endoscopic Carpal Tunnel Release Disposable Blade Assembly
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® Remanufactured2018-07-06 Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fract
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