SPOTLIGHT 282918080

GUDID 10705034206431

SPOTLIGHT ACCESS SYSTEM ILLUMINATED STRAIGHT PORT 18 x 80mm

DEPUY SPINE, LLC

Endoscopic light source unit, line-powered

• Primary Device ID: 10705034206431
• NIH Device Record Key: 04dcb4ef-bffb-41a1-b353-cdfed3bc1a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPOTLIGHT
• Version Model Number: 282918080
• Catalog Number: 282918080
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034206431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062814

FDA Product Code

• GZT: RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

[10705034206431]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-12-22
• Device Publish Date: 2016-06-30

On-Brand Devices [SPOTLIGHT]

• 10705034225258: SPOTLIGHT ACCESS SYSTEM INTRODUCER
• 10705034225661: SPOTLIGHT ACCESS SYSTEM DOWN ANGLE CURETTE 4mm
• 10705034225654: SPOTLIGHT ACCESS SYSTEM DOWN BITING CURETTE 4mm
• 10705034225647: SPOTLIGHT ACCESS SYSTEM UP ANGLE CURETTE 4mm
• 10705034225630: SPOTLIGHT ACCESS SYSTEM REVERSE CURETTE 4mm
• 10705034225623: SPOTLIGHT ACCESS SYSTEM STRAIGHT CURETTE 4mm
• 10705034225616: SPOTLIGHT ACCESS SYSTEM DOWN ANGLE CURETTE 3mm
• 10705034225609: SPOTLIGHT ACCESS SYSTEM DOWN BITING CURETTE 3mm
• 10705034225593: SPOTLIGHT ACCESS SYSTEM UP ANGLE CURETTE 3mm
• 10705034225586: SPOTLIGHT ACCESS SYSTEM REVERSE CURETTE 3mm
• 10705034225579: SPOTLIGHT ACCESS SYSTEM STRAIGHT CURETTE 3mm
• 10705034225562: SPOTLIGHT ACCESS SYSTEM DOWN ANGLE CURETTE 2mm
• 10705034225555: SPOTLIGHT ACCESS SYSTEM DOWN BITING CURETTE 2mm
• 10705034225548: SPOTLIGHT ACCESS SYSTEM UP ANGLE CURETTE 2mm
• 10705034225531: SPOTLIGHT ACCESS SYSTEM REVERSE CURETTE 2mm
• 10705034225524: SPOTLIGHT ACCESS SYSTEM STRAIGHT CURETTE 2mm
• 10705034225173: Spotlight access system Fiberoptic light guides
• 10705034225937: SPOTLIGHT ACCESS SYSTEM BAYONETED SCALPEL HOLDER
• 10705034359250: SPOTLIGHT PL CANNULATED REAMER 13mm
• 10705034359243: SPOTLIGHT PL CANNULATED REAMER 9mm
• 10705034359236: SPOTLIGHT PL CANNULATED REAMER 8mm
• 10705034359229: SPOTLIGHT PL CANNULATED REAMER 7mm
• 10705034359212: SPOTLIGHT PL CANNULATED REAMER 6mm
• 10705034359267: SPOTLIGHT PL PLF CASE 1
• 10705034226002: SPOTLIGHT ACCESS SYSTEM HALF TRAY 24mm
• 10705034225999: SPOTLIGHT ACCESS SYSTEM HALF TRAY 21mm
• 10705034225982: SPOTLIGHT ACCESS SYSTEM HALF TRAY 18mm
• 10705034225975: SPOTLIGHT ACCESS SYSTEM HALF TRAY 15mm
• 10705034225968: SPOTLIGHT ACCESS SYSTEM HALF TRAY 12mm
• 10705034225425: SPOTLIGHT ACCESS SYSTEM CASE LID
• 10705034225418: SPOTLIGHT ACCESS SYSTEM 3-LEVEL PORT CASE
• 10705034225401: SPOTLIGHT ACCESS SYSTEM TRAY LID
• 10705034225395: SPOTLIGHT ACCESS SYSTEM CORE INSTRUMENTS HALF TRAY
• 10705034225388: SPOTLIGHT ACCESS SYSTEM 2-LEVEL PORT CASE
• 10705034225371: SPOTLIGHT ACCESS SYSTEM 4-LEVEL PORT CASE
• 10705034225364: SPOTLIGHT ACCESS SYSTEM RIGID ARM CASE
• 10705034225333: SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2, TRAY 3
• 10705034225326: SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2, TRAY 2
• 10705034225319: SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2, TRAY 1
• 10705034225302: SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 2
• 10705034225296: SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 1, TRAY 2
• 10705034225289: SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 1, TRAY 1
• 10705034225272: SPOTLIGHT ACCESS SYSTEM MICRODISCECTOMY CASE Number 1
• 10705034359328: SPOTLIGHT PL LIGHTED BLADE LEFT 80mm
• 10705034359298: SPOTLIGHT PL LIGHTED BLADE LEFT 50mm
• 10705034359137: SPOTLIGHT PL BLADE MIDDLE 50mm
• 10705034359106: SPOTLIGHT PL BLADE RIGHT 80mm
• 10705034359076: SPOTLIGHT PL BLADE RIGHT 50mm
• 10705034359045: SPOTLIGHT PL BLADE LEFT 80mm
• 10705034359014: SPOTLIGHT PL BLADE LEFT 50mm