Primary Device ID | 00849771005797 |
NIH Device Record Key | a48f52d1-0ebb-46a7-8f75-100ebb87ad59 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | PW10FPMT |
Catalog Number | PW10FPMT |
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 | 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 | 00849771005797 [Primary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-10 |
Device Publish Date | 2023-11-02 |
00849771047643 - NA | 2024-04-01 Instrument Stringers, Center Lock Stringer, Surgical Stainless Steel, 6-inch x 3-inch |
00849771048077 - NA | 2024-04-01 German Stainless Steel Pliers, Locking Pliers, 8-inch medium |
00849771048220 - NA | 2024-04-01 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 12-inch long |
00849771048244 - NA | 2024-04-01 K-Wire and Steinmann Pin Dispensers, 3/32-inch (2.4mm) diameter, Holds pins up to 12-inch long |
10849771050473 - NA | 2024-04-01 Suture Booties, White, Sterile, 5 pair per pad |
00849771051275 - NA | 2024-04-01 Endoscope Brush, 150cm long, 4.2mm dia, 2cm BAL, Nylon Bristles, pink polypropylene tubing |
00849771051534 - Key Surgical Endoscope Brushes | 2024-04-01 Specialty Cleaning Brushes, nylon, ss spring coil wire, 3-5mm tapered, bead |
00849771051619 - Key Surgical Endoscope Brushes | 2024-04-01 Specialty Cleaning Brushes, Nylon bristles on both ends, rigid plastic tubing, 3-5 mm tapered diameter |