Primary Device ID | 50849771050624 |
NIH Device Record Key | 6e605a67-4f31-4a67-9291-42e804395af0 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | K-Wire and Pin Covers |
Catalog Number | C125 |
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 | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00849771000983 [Previous] |
GS1 | 00849771050629 [Unit of Use] |
GS1 | 10849771050626 [Primary] |
GS1 | 50849771050624 [Package] Contains: 10849771050626 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 | 2024-10-11 |
Device Publish Date | 2024-10-03 |
00849771046356 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 20 |
00849771046363 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 22 |
00849771046370 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 24 |
00849771046387 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 25 |
00849771046394 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 26 |
00849771013372 - Key Surgical Cautery Tip Cleaner | 2025-04-14 Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch |
50849771050617 - NA | 2025-03-17 Pin Covers, Sterile, Tan, 2 per package |
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. |