The Tether™
GUDID 00880304979215
BONE SCREW DRIVER
ZIMMER BIOMET INC
Orthopaedic implant inserter/extractor, reusable| Primary Device ID | 00880304979215 |
| NIH Device Record Key | 0d0e0648-7336-464e-8528-5ce657b61585 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Tether™ |
| Version Model Number | 230H4002 |
| Company DUNS | 045576443 |
| Company Name | ZIMMER BIOMET INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00880304979215 [Primary] |
FDA Product Code
| HXX | Screwdriver |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
[00880304979215]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-21 |
| Device Publish Date | 2019-11-13 |
On-Brand Devices [The Tether™]
| 00887868337772 | RATCHETING PALM HANDLE |
| 00887868262890 | CORD ALIGNMENT ROD |
| 00887868250583 | 7.0MM TAP |
| 00887868250576 | 6.5MM TAP |
| 00887868250569 | 6.0MM TAP |
| 00887868250552 | 5.5MM TAP |
| 00887868250545 | 5.0MM TAP |
| 00887868250538 | 4.5MM TAP |
| 00887868250521 | EXTENSION SPRING TUBE SHORT |
| 00887868250514 | EXTENSION SPRING TUBE LONG |
| 00887868247002 | AWL LONG |
| 00887868246999 | FINE ADJUSTMENT KNOB |
| 00887868246098 | 5.0MM TAP |
| 00887868227455 | CORD TENSIONER |
| 00887868227448 | COUNTER TENSIONER |
| 00887868227431 | SET SCREW DRIVER |
| 00887868227424 | K-WIRE DISPENSER |
| 00887868227417 | K-WIRE |
| 00887868227400 | SOUNDER |
| 00887868227387 | ANCHOR INSERTER INNER DTS |
| 00887868227370 | ANCHOR INSERTER OUTER DTS |
| 00887868227363 | ANCHOR INSERTER 90DEG HANDLE |
| 00887868227349 | ANCHOR INSERTER STANDARD AWL |
| 00887868214202 | 5.5MM TAP |
| 00887868214196 | 7.0MM TAP |
| 00887868214189 | 6.5MM TAP |
| 00887868214172 | 6.0MM TAP |
| 00880304979239 | RATCHETING IN LINE HANDLE |
| 00880304979222 | TORQUE LIMITING HANDLE |
| 00880304979215 | BONE SCREW DRIVER |
| 00880304865327 | 7.0MM DIA X 50MM VBT ASSY |
| 00880304865310 | 7.0MM DIA X 47.5MM VBT ASSY |
| 00880304865303 | 7.0MM DIA X 45MM VBT ASSY |
| 00880304865297 | 7.0MM DIA X 42.5MM VBT ASSY |
| 00880304865280 | 7.0MM DIA X 40MM VBT ASSY |
| 00880304865273 | 7.0MM DIA X 37.5MM VBT ASSY |
| 00880304865266 | 7.0MM DIA X 35MM VBT ASSY |
| 00880304865259 | 7.0MM DIA X 32.5MM VBT ASSY |
| 00880304865242 | 7.0MM DIA X 30MM VBT ASSY |
| 00880304865235 | 7.0MM DIA X 27.5MM VBT ASSY |
| 00880304865228 | 7.0MM DIA X 25MM VBT ASSY |
| 00880304865211 | 7.0MM DIA X 22.5MM VBT ASSY |
| 00880304865204 | 7.0MM DIA X 20MM VBT ASSY |
| 00880304865198 | 6.5MM DIA X 50MM VBT ASSY |
| 00880304865181 | 6.5MM DIA X 47.5MM VBT ASSY |
| 00880304865174 | 6.5MM DIA X 45MM VBT ASSY |
| 00880304865167 | 6.5MM DIA X 42.5MM VBT ASSY |
| 00880304865150 | 6.5MM DIA X 40MM VBT ASSY |
| 00880304865143 | 6.5MM DIA X 37.5MM VBT ASSY |
| 00880304865136 | 6.5MM DIA X 35MM VBT ASSY |
Trademark Results [The Tether]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE TETHER 88637747 not registered Live/Pending |
Zimmer Biomet Spine, Inc. 2019-10-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.