Primary Device ID | 00849771051275 |
NIH Device Record Key | 8b84ff1c-3d80-44da-9263-edb8d6d5372b |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | BR15042 |
Catalog Number | BR15042 |
Company DUNS | 604056226 |
Company Name | KEY SURGICAL, INC. |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00849771017813 [Previous] |
GS1 | 00849771051275 [Primary] |
MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
[00849771051275]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-01 |
Device Publish Date | 2024-03-22 |
00849771048169 - NA | 2025-05-08 K-Wire and Steinmann Pin Dispensers, .035 inch .9mm diameter, Holds kwires up to 6 inch long |
00849771049012 - NA | 2025-05-08 K-Wires, Double trocar, .054-inch (1.4mm) diameter, 12-inch long |
00849771049128 - NA | 2025-05-08 K-Wires, Single trocar, .035-inch (.9mm) diameter, 12-inch long |
60849771050416 - Electro Lube | 2025-05-02 Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking. |
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 |