Entrada ™

GUDID 08714729950684

Needle 11cm (4.5in)

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Epidural needle, non-threaded

• Primary Device ID: 08714729950684
• NIH Device Record Key: af92b014-b1f8-4b9e-9daf-319cd8360776
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entrada ™
• Version Model Number: SC-4220-45
• 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: false
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729950684 [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: 2025-08-25
• Device Publish Date: 2017-04-04

On-Brand Devices [Entrada ™]

• 08714729861652: Needle
• 08714729950714: Spare Sheath 15cm (6.0 in)
• 08714729950707: Spare Sheath 11cm (4.5 in)
• 08714729950691: Needle 15cm (6.0 in)
• 08714729950684: Needle 11cm (4.5in)