Primary Device ID | 10849771051012 |
NIH Device Record Key | bfe404f0-4ff6-4ac5-a99a-240da1575b93 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | Skin Marker |
Catalog Number | SM300 |
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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00849771030485 [Previous] |
GS1 | 00849771051015 [Primary] |
GS1 | 10849771051012 [Package] Contains: 00849771051015 Package: Box [50 Units] In Commercial Distribution |
FZZ | MARKER, SKIN |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-20 |
Device Publish Date | 2024-02-12 |
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 |