| Primary Device ID | 00840606152396 |
| NIH Device Record Key | c00e0652-939e-475c-9739-eb23b22b8cb0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lucent-L |
| Version Model Number | 11842-611 |
| 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 | 00840606152396 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
[00840606152396]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2019-11-19 |
| 00840606157360 | LUCENT® L LATERAL SLED |
| 00840606157353 | LUCENT® LATERAL 22MM 18° CADDY LID |
| 00840606157346 | LUCENT® LATERAL 22MM 18° CADDY BASE |
| 00840606157339 | LUCENT® LATERAL 22MM 18° CADDY ASSEMBLY |
| 00840606157322 | LUCENT® LATERAL 22MM 18° BOTTOM INSERT |
| 00840606157315 | LUCENT® LATERAL 22MM 18° TOP INSERT |
| 00840606157308 | LUCENT® LATERAL 22MM 18° LID |
| 00840606157292 | LUCENT® LATERAL 22MM 18° TRAY BASE |
| 00840606157285 | LUCENT® LATERAL 22MM 18° TRAY ASSEMBLY |
| 00840606157254 | LUCENT® LATERAL 18MM X 12° CADDY LID |
| 00840606157247 | LUCENT® LATERAL 18MM X 12° CADDY BASE |
| 00840606157230 | LUCENT® LATERAL 18MM X 12° CADDY ASSEMBLY |
| 00840606145589 | LUCENT® OLYMPUS ADAPTER |
| 00840606145572 | LUCENT® ACMI ADAPTER |
| 00840606145565 | RETRACTOR ADAPTER |
| 00840606145558 | LIGHT CABLE ADAPTER, RIGHT |
| 00840606145541 | LIGHT CABLE ADAPTER, LEFT |
| 00840606145534 | RIGHT BLADE, 120MM |
| 00840606145527 | RIGHT BLADE, 110MM |
| 00840606145510 | RIGHT BLADE, 100MM |
| 00840606145503 | RIGHT BLADE, 90MM |
| 00840606145497 | RIGHT BLADE, 80MM |
| 00840606145480 | RIGHT BLADE, 70MM |
| 00840606145473 | RIGHT BLADE, 60MM |
| 00840606145466 | RIGHT BLADE, 50MM |
| 00840606145459 | RIGHT BLADE, 40MM |
| 00840606145442 | LEFT BLADE, 120MM |
| 00840606155892 | LUCENT® L ANGLED OFFSET INSERTER |
| 00840606155885 | LUCENT® L OFFSET INSERTER |
| 00840606155847 | LUCENT® L ANGLED IMPLANT INSERTER |
| 00840606155618 | LUCENT® L SLAP HAMMER ADAPTER, OFFSET INSERTER |
| 00840606145749 | LUCENT® L 1.5MM NITINOL K-WIRE |
| 00840606145732 | LUCENT® L RETRACTOR BODY TOOL |
| 00840606145725 | LUCENT® L ANTERIOR PROBE, ANODIZED, 180MM |
| 00840606145718 | LUCENT® L ANTERIOR PROBE, ANODIZED, 130MM |
| 00840606145701 | LUCENT® L BLADE EXTENSION INSERTER |
| 00840606145695 | LUCENT® L DILATOR HOLDER |
| 00840606145688 | LUCENT® L POSTERIOR PROBE, ANODIZED, 180MM |
| 00840606145671 | LUCENT® L POSTERIOR PROBE, ANODIZED, 130MM |
| 00840606145657 | SURGICAL ARM ASSEMBLY, 45° |
| 00840606145640 | SURGICAL ARM ASSEMBLY |
| 00840606145633 | SURGICAL ARM BASIC CLAMP |
| 00840606145626 | SURGICAL ARM RADIAL CLAMP |
| 00840606145619 | SURGICAL ARM |
| 00840606145602 | LUCENT® WOLF ADAPTER |
| 00840606145596 | LUCENT® STORZ ADAPTER |
| 00840606145848 | LUCENT® L LONG ENDPLATE SCRAPER, ANGLED STIRRUP |
| 00840606145831 | LUCENT® L LONG ENDPLATE SCRAPER, FLAT STIRRUP |
| 00840606145824 | LUCENT® L LONG STRAIGHT PITUITARY, 6MM |
| 00840606145817 | LUCENT® L LONG STRAIGHT PITUITARY, 5MM |