Primary Device ID | 00840606162258 |
NIH Device Record Key | 96d073b5-3ba2-48a8-b24f-856c1344b07c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TELEGRAFT |
Version Model Number | 11397-010 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, 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 | 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 Issuing Agency | Device ID |
---|---|
GS1 | 00840606162258 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
[00840606162258]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-05-03 |
Device Publish Date | 2020-11-10 |
00840606163392 | TeleGraft™ Delivery System - Tray Insert |
00840606163385 | TeleGraft™ Delivery System - Tray Base |
00840606163378 | TeleGraft™ Delivery System - Tray Lid |
00840606163361 | TeleGraft™ Delivery System - Tray Assembly |
00840606154628 | GRAFT LOADING SLEEVE |
00840606167321 | Luna® Self-Pack Graft Portal |
00840606167314 | Luna® Graft Portal - Large |
00840606167307 | Luna® Graft Portal - Small |
00840606162258 | CARTRIDGE PUSHER |
00840606162241 | GRAFT PORTAL |
00840606162234 | BREAK-ACTION GRAFT GUN |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TELEGRAFT 90573622 not registered Live/Pending |
Spinal Elements, Inc. 2021-03-11 |
TELEGRAFT 88806413 not registered Live/Pending |
Spinal Elements, Inc. 2020-02-21 |