Primary Device ID | 00842078109366 |
NIH Device Record Key | c828ac97-888e-4c79-a6d9-5eca751e5f9b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CarpalFiX |
Version Model Number | 127-00000 |
Company DUNS | 832720358 |
Company Name | EXTREMITY MEDICAL, LLC |
Device Count | 1 |
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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00842078109366 [Primary] |
FSM | Tray, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
[00842078109366]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-08 |
Device Publish Date | 2024-03-29 |
00842078109991 | X-Post (75 deg) 4.6 X 18mm |
00842078109984 | X-Post (75 deg) 4.6 X 16mm |
00842078109977 | X-Post (75 deg) 4.6 X 14mm |
00842078109960 | X-Post (75 deg) 4.6 X 12mm |
00842078109953 | X-Post (75 deg) 4.6 X 10mm |
00842078109939 | X-Post (60 deg) 4.6 X 18mm |
00842078109915 | X-Post (60 deg) 4.6 X 16mm |
00842078109892 | X-Post (60 deg) 4.6 X 14mm |
00842078109878 | X-Post (60 deg) 4.6 X 12mm |
00842078109854 | X-Post (60 deg) 4.6 X 10mm |
00842078109830 | X-Post (45 deg) 4.6 X 18mm |
00842078109823 | X-Post (45 deg) 4.6 X 16mm |
00842078109816 | X-Post (45 deg) 4.6 X 14mm |
00842078109809 | X-Post (45 deg) 4.6 X 12mm |
00842078109793 | X-Post (45 deg) 4.6 X 10mm |
00842078109724 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 30mm |
00842078109717 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 28mm |
00842078109700 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 26mm |
00842078109694 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 24mm |
00842078109687 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 22mm |
00842078109670 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 20mm |
00842078109663 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 18mm |
00842078109656 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 16mm |
00842078109649 | Short Thread Lag Screw (Cannulated Tapered) 3.0 x 14mm |
00842078109571 | Lag Screw (Cannulated Tapered) 3.0 x 30mm |
00842078109564 | Lag Screw (Cannulated Tapered) 3.0 x 28mm |
00842078109557 | Lag Screw (Cannulated Tapered) 3.0 x 26mm |
00842078109540 | Lag Screw (Cannulated Tapered) 3.0 x 24mm |
00842078109533 | Lag Screw (Cannulated Tapered) 3.0 x 22mm |
00842078109526 | Lag Screw (Cannulated Tapered) 3.0 x 20mm |
00842078109519 | Lag Screw (Cannulated Tapered) 3.0 x 18mm |
00842078109502 | Lag Screw (Cannulated Tapered) 3.0 x 16mm |
00842078109496 | Lag Screw (Cannulated Tapered) 3.0 x 14mm |
00842078109946 | X-Post (60 deg) 4.6 x 18 mm (S. Wolfe) |
00842078109922 | X-Post (60 deg) 4.6 x 16 mm (S. Wolfe) |
00842078109908 | X-Post (60 deg) 4.6 x 14 mm (S. Wolfe) |
00842078109885 | X-Post (60 deg) 4.6 x 12 mm (S. Wolfe) |
00842078109861 | X-Post (60 deg) 4.6 x 10 mm (S. Wolfe) |
00842078109366 | Instrument Tray |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CARPALFIX 85421545 4377050 Live/Registered |
Extremity Medical, LLC 2011-09-13 |
CARPALFIX 85418001 4377045 Live/Registered |
Extremity Medical, LLC 2011-09-08 |