Primary Device ID | 60849771028361 |
NIH Device Record Key | 971a5286-daa0-4492-90e5-c52eff8faf9f |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | PP1875050 |
Catalog Number | PP1875050 |
Company DUNS | 604056226 |
Company Name | KEY SURGICAL, INC. |
Device Count | 50 |
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 | false |
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 | 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 | 00849771028369 [Primary] |
GS1 | 60849771028361 [Unit of Use] |
MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
[60849771028361]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-24 |
Device Publish Date | 2024-07-16 |
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. |