Primary Device ID | 00861994000281 |
NIH Device Record Key | d0d2f3a3-5560-49ee-aab8-cf3fcb166368 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Disposable Blade Assembly |
Version Model Number | CTR-455 |
Catalog Number | CTR-455 |
Company DUNS | 620754127 |
Company Name | Hand Biomechanics Lab Inc |
Device Count | 6 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com | |
Phone | 916-923-5073 |
info@handbiolab.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00861994000281 [Unit of Use] |
GS1 | 10861994000288 [Primary] |
EMF | Knife, Surgical |
HRX | Arthroscope |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-12-14 |
Device Publish Date | 2021-12-06 |
00861994000281 - Disposable Blade Assembly | 2021-12-14Endoscopic Carpal Tunnel Release Disposable Blade Assembly |
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® | 2018-07-06 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 |