Primary Device ID | 50849771050631 |
NIH Device Record Key | df1fb9dc-2e58-4ce8-92db-0a20682f3305 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | K-Wire and Pin Covers |
Catalog Number | C141 |
Company DUNS | 604056226 |
Company Name | KEY SURGICAL, INC. |
Device Count | 2 |
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 | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00849771000976 [Previous] |
GS1 | 00849771050636 [Unit of Use] |
GS1 | 10849771050633 [Primary] |
GS1 | 50849771050631 [Package] Contains: 10849771050633 Package: Box [12 Units] In Commercial Distribution |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-09 |
Device Publish Date | 2024-08-01 |
00849771048503 - NA | 2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm |
00849771052180 - Instrument Stringers | 2024-08-30 Instrument Stringer, U-Shaped Stringer, Surgical Stainless Steel, 16-inch x 2.75-inch |
00849771050162 - NA | 2024-08-30 Steinmann Pins, Double trocar threaded, 7/64-inch (2.8mm) diameter, 9-inch long |
10849771050466 - NA | 2024-08-09 Suture Booties, Red, Sterile, 5 pair per pad |
50849771050631 - NA | 2024-08-09Pin Covers, Sterile, Brown, 2 per package |
50849771050631 - NA | 2024-08-09 Pin Covers, Sterile, Brown, 2 per package |
50849771050846 - NA | 2024-08-09 Vascular Loops, Sterile, Blue, Super Maxi, 18-inch long, 2 per package |
60849771028132 - NA | 2024-07-24 Polypropylene Channel Brush BLUE 16 INCH L 0.039 INCH DIAMETER |
60849771028149 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.039 INCH DIAMETER |