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 |
10724995225022 - Electro Lube | 2024-10-11 Electro Lube NXT is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking. |
00849771048190 - NA | 2024-10-11 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 6-inch long |
00849771052562 - Key Surgical Pipe Cleaners | 2024-10-11 Pipe Cleaner, 1/8-inch Cotton, 50 feet |
00849771050131 - NA | 2024-10-11 Steinmann Pins, Double diamond, threaded, .177-inch (4.5mm) diameter, 9-inch long |
50849771050563 - NA | 2024-10-11 K-Wire Covers, Sterile, White, 2 per package |
50849771050624 - NA | 2024-10-11 Pin Covers, Sterile, Lavender, 2 per package |
50849771050655 - NA | 2024-10-11 Pin Covers, Sterile, Orange, 0.177-inch, 2 per package |
00849771048503 - NA | 2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm |