| Primary Device ID | 00861994000236 |
| NIH Device Record Key | 2f10aca4-0763-4155-b009-2db969729363 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Agee WristJack® Remanufactured |
| Version Model Number | CFD-147-RNS |
| Catalog Number | CFD-147-R |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com | |
| Phone | 800-522-5778 |
| info@handbiolab.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00861994000236 [Primary] |
| JEC | Component, Traction, Invasive |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[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
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-23 |
| 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 | 2018-07-06Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fractures. |
| 00861994000236 - Agee WristJack® Remanufactured | 2018-07-06 Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fract |