BENGAL 187302309

GUDID 10705034137643

BENGAL SYSTEM EXTRA LARGE IMPLANT 9mm

DEPUY SPINE, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: 10705034137643
• NIH Device Record Key: a85b6c4b-675b-4cc5-a163-7d0a7df2acc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BENGAL
• Version Model Number: 187302309
• Catalog Number: 187302309
• 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: true
• 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
• 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	10705034137643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031635

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

[10705034137643]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-24

On-Brand Devices [BENGAL]

• 10705034197791: BENGAL STACKABLE CAGE SYSTEM DISTRACTOR PIN FOOT XLG
• 10705034197784: BENGAL STACKABLE CAGE SYSTEM DISTRACTOR PIN FOOT LRG
• 10705034197777: BENGAL STACKABLE CAGE SYSTEM DISTRACTOR PIN FOOT STD
• 10705034197715: BENGAL STACKABLE CAGE SYSTEM CAGE INSERTER TIP
• 10705034197708: BENGAL STACKABLE CAGE SYSTEM CAGE INSERTER
• 10705034189345: BENGAL SYSTEM INLINE INSERTER
• 10705034187990: BENGAL SYSTEM INSERTER
• 10705034137650: BENGAL SYSTEM EXTRA LARGE 10mm
• 10705034137643: BENGAL SYSTEM EXTRA LARGE IMPLANT 9mm
• 10705034137636: BENGAL SYSTEM EXTRA LARGE IMPLANT 8mm
• 10705034137629: BENGAL SYSTEM EXTRA LARGE IMPLANT 7mm
• 10705034137612: BENGAL SYSTEM EXTRA LARGE IMPLANT 6mm
• 10705034137605: BENGAL SYSTEM EXTRA LARGE IMPLANT 5mm
• 10705034137537: BENGAL SYSTEM LARGE IMPLANT 10mm
• 10705034137520: BENGAL SYSTEM LARGE IMPLANT 9mm
• 10705034137513: BENGAL SYSTEM LARGE IMPLANT 8mm
• 10705034137506: BENGAL SYSTEM LARGE IMPLANT 7mm
• 10705034137490: BENGAL SYSTEM LARGE IMPLANT 6mm
• 10705034137483: BENGAL SYSTEM LARGE IMPLANT 5mm
• 10705034137476: BENGAL SYSTEM LARGE IMPLANT, PARALLEL 4mm
• 10705034137469: BENGAL SYSTEM STANDARD IMPLANT 16mm
• 10705034137452: BENGAL SYSTEM STANDARD IMPLANT 15mm
• 10705034137445: BENGAL SYSTEM STANDARD IMPLANT 14mm
• 10705034137438: BENGAL SYSTEM STANDARD IMPLANT 13mm
• 10705034137421: BENGAL SYSTEM STANDARD IMPLANT 12mm
• 10705034137414: BENGAL SYSTEM STANDARD IMPLANT 11mm
• 10705034137407: BENGAL SYSTEM STANDARD IMPLANT 10mm
• 10705034137391: BENGAL SYSTEM STANDARD IMPLANT 9mm
• 10705034137384: BENGAL SYSTEM STANDARD IMPLANT 8mm
• 10705034137377: BENGAL SYSTEM STANDARD IMPLANT 7mm
• 10705034137360: BENGAL SYSTEM STANDARD IMPLANT 6mm
• 10705034137353: BENGAL SYSTEM STANDARD IMPLANT 5mm
• 10705034137346: BENGAL SYSTEM STANDARD IMPLANT, PARALLEL 4mm
• 10705034137209: BENGAL SYSTEM LARGE IMPLANT 16mm, 7 DEGREES
• 10705034137193: BENGAL SYSTEM LARGE IMPLANT 15mm, 7 DEGREES
• 10705034137186: BENGAL SYSTEM LARGE IMPLANT 14mm, 7 DEGREES
• 10705034137179: BENGAL SYSTEM LARGE IMPLANT 13mm, 7 DEGREES
• 10705034137162: BENGAL SYSTEM LARGE IMPLANT 12mm, 7 DEGREES
• 10705034137155: BENGAL SYSTEM LARGE IMPLANT 11mm, 7 DEGREES
• 10705034137148: BENGAL SYSTEM LARGE IMPLANT 10mm, 7 DEGREES
• 10705034137131: BENGAL SYSTEM LARGE IMPLANT 9mm, 7 DEGREES
• 10705034137124: BENGAL SYSTEM LARGE IMPLANT 8mm, 7 DEGREES
• 10705034137117: BENGAL SYSTEM LARGE IMPLANT 7mm, 7 DEGREES
• 10705034137100: BENGAL SYSTEM LARGE IMPLANT 6mm, 7 DEGREES
• 10705034137094: BENGAL SYSTEM LARGE IMPLANT 5mm, 7 DEGREES
• 10705034137087: BENGAL SYSTEM LARGE IMPLANT 4mm, 7 DEGREES
• 10705034137070: BENGAL SYSTEM STANDARD IMPLANT 16mm, 7 DEGREES
• 10705034137063: BENGAL SYSTEM STANDARD IMPLANT 15mm, 7 DEGREES
• 10705034137056: BENGAL SYSTEM STANDARD IMPLANT 14mm, 7 DEGREES
• 10705034137049: BENGAL SYSTEM STANDARD IMPLANT 13mm, 7 DEGREES