Primary Device ID | 00840606176637 |
NIH Device Record Key | 7c8d1dee-93f9-493a-bed7-cbf195cfac38 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sapphire X3 |
Version Model Number | 27071-024 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | 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 | 00840606176637 [Primary] |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
[00840606176637]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-12 |
Device Publish Date | 2024-02-02 |
00840606181259 | SAPPHIRE X 3-HOLE INSERTER,SHORT |
00840606181310 | SAPPHIRE X 3-HOLE INSERTER, HANDLE |
00840606181303 | SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLY LONG |
00840606181297 | SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLY MEDIUM |
00840606181280 | SAPPHIRE X 3-HOLE INSERTER, SHAFT ASSEMBLYSHORT |
00840606181273 | SAPPHIRE X 3-HOLE INSERTER,LONG |
00840606181266 | SAPPHIRE X 3-HOLE INSERTER,MEDIUM |
00840606178358 | 1-LEVEL SAPPHIRE X3, 27MM, 17.5MM WIDE |
00840606178341 | 1-LEVEL SAPPHIRE X3, 26MM, 17.5MM WIDE |
00840606178334 | 1-LEVEL SAPPHIRE X3, 25MM, 17.5MM WIDE |
00840606178327 | 1-LEVEL SAPPHIRE X3, 24MM, 17.5MM WIDE |
00840606178310 | 1-LEVEL SAPPHIRE X3, 23MM, 17.5MM WIDE |
00840606178303 | 1-LEVEL SAPPHIRE X3, 22MM, 17.5MM WIDE |
00840606178297 | 1-LEVEL SAPPHIRE X3, 21MM, 17.5MM WIDE |
00840606178280 | 1-LEVEL SAPPHIRE X3, 20MM, 17.5MM WIDE |
00840606178273 | 1-LEVEL SAPPHIRE X3, 19MM, 17.5MM WIDE |
00840606178266 | 1-LEVEL SAPPHIRE X3, 18MM, 17.5MM WIDE |
00840606178259 | 1-LEVEL SAPPHIRE X3, 17MM, 17.5MM WIDE |
00840606178242 | 1-LEVEL SAPPHIRE X3, 16MM, 17.5MM WIDE |
00840606178235 | 1-LEVEL SAPPHIRE X3, 15MM, 17.5MM WIDE |
00840606178228 | 1-LEVEL SAPPHIRE X3, 14MM, 17.5MM WIDE |
00840606178211 | 1-LEVEL SAPPHIRE X3, 13MM, 17.5MM WIDE |
00840606178204 | 1-LEVEL SAPPHIRE X3, 12MM, 17.5MM WIDE |
00840606178198 | 1-LEVEL SAPPHIRE X3, 11MM, 17.5MM WIDE |
00840606178181 | 1-LEVEL SAPPHIRE X3, 10MM, 17.5MM WIDE |
00840606178174 | 1-LEVEL SAPPHIRE X3, 9MM, 17.5.MM WIDE |
00840606178167 | 1-LEVEL SAPPHIRE X3, 8MM, 17.5MM WIDE |
00840606176668 | 1-LEVEL SAPPHIRE X3, 27MM, 16.5MM WIDE |
00840606176651 | 1-LEVEL SAPPHIRE X3, 26MM, 16.5MM WIDE |
00840606176644 | 1-LEVEL SAPPHIRE X3, 25MM, 16.5MM WIDE |
00840606176637 | 1-LEVEL SAPPHIRE X3, 24MM, 16.5MM WIDE |
00840606176620 | 1-LEVEL SAPPHIRE X3, 23MM, 16.5MM WIDE |
00840606176613 | 1-LEVEL SAPPHIRE X3, 22MM, 16.5MM WIDE |
00840606176606 | 1-LEVEL SAPPHIRE X3, 21MM, 16.5MM WIDE |
00840606176590 | 1-LEVEL SAPPHIRE X3, 20MM, 16.5MM WIDE |
00840606176583 | 1-LEVEL SAPPHIRE X3, 19MM, 16.5MM WIDE |
00840606176576 | 1-LEVEL SAPPHIRE X3, 18MM, 16.5MM WIDE |
00840606176569 | 1-LEVEL SAPPHIRE X3, 17MM, 16.5MM WIDE |
00840606176552 | 1-LEVEL SAPPHIRE X3, 16MM, 16.5MM WIDE |
00840606176545 | 1-LEVEL SAPPHIRE X3, 15MM, 16.5MM WIDE |
00840606176538 | 1-LEVEL SAPPHIRE X3, 14MM, 16.5MM WIDE |
00840606176521 | 1-LEVEL SAPPHIRE X3, 13MM, 16.5MM WIDE |
00840606176514 | 1-LEVEL SAPPHIRE X3, 12MM, 16.5MM WIDE |
00840606176507 | 1-LEVEL SAPPHIRE X3, 11MM, 16.5MM WIDE |
00840606176491 | 1-LEVEL SAPPHIRE X3, 10MM, 16.5MM WIDE |
00840606176484 | 1-LEVEL SAPPHIRE X3, 9MM, 16.5.MM WIDE |
00840606176477 | 1-LEVEL SAPPHIRE X3, 8MM, 16.5MM WIDE |
00840606176323 | Ø3.5MM X 20MM SELF-DRILLING,FIXED ANGLE SCREW |
00840606176316 | Ø3.5MM X 19MM SELF-DRILLING,FIXED ANGLE SCREW |
00840606176309 | Ø3.5MM X 18MM SELF-DRILLING,FIXED ANGLE SCREW |