Primary Device ID | 00819917026832 |
NIH Device Record Key | ccb76fb0-53b4-4d60-a8b9-7d65642f3c27 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cannulated Screw System + |
Version Model Number | 03.333.213S |
Catalog Number | 03.333.213S |
Company DUNS | 010968002 |
Company Name | Tyber Medical, LLC |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com | |
Phone | +1(866)761-0933 |
jstigliano@tybermed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00819917026832 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2025-08-15 |
Device Publish Date | 2020-05-21 |
00196449008940 - UNITUS | 2025-08-15 8Bx8Lx8R STERILE KIT |
00196449008957 - UNITUS | 2025-08-15 10Bx8Lx8R STERILE KIT |
00196449008964 - UNITUS | 2025-08-15 15Bx12Lx12R STERILE KIT |
00196449008971 - UNITUS | 2025-08-15 15Bx15Lx15R STERILE KIT |
00196449008988 - UNITUS | 2025-08-15 18Bx18Lx18R STERILE KIT |
00196449008995 - UNITUS | 2025-08-15 20Bx18Lx18R STERILE KIT |
00196449009008 - UNITUS | 2025-08-15 20Bx20Lx20R STERILE KIT |
00196449009015 - UNITUS | 2025-08-15 25Bx20Lx20R STERILE KIT |