Entrada ™ SC-4220

GUDID 08714729861652

Needle

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded Epidural needle, non-threaded

• Primary Device ID: 08714729861652
• NIH Device Record Key: 24695247-e64f-4ff8-bdeb-c367a1af3b38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entrada ™
• Version Model Number: SC-4220
• Catalog Number: SC-4220
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729861652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-03-19
• Device Publish Date: 2015-10-10

Devices Manufactured by BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

• 08714729121688 - Precision ™: 2024-03-25 Adhesive Kit
• 08714729121435 - Precision™: 2024-03-19 Hex Wrench
• 08714729121442 - NA: 2024-03-19 10cm (4 Inch) Insertion Needle
• 08714729121459 - NA: 2024-03-19 13cm (5 Inch) Insertion Needle
• 08714729121497 - NA: 2024-03-19 Stylet Kit with Stylet Cap 30cm
• 08714729121503 - NA: 2024-03-19 Stylet Kit with Stylet Cap 50cm
• 08714729121510 - NA: 2024-03-19 Stylet Kit with Stylet Cap 70cm
• 08714729121558 - NA: 2024-03-19 Enhanced Steering Kit with Stylet Cap 30cm