Eclipse

GUDID M970150000061208

ECLIPSE Soft Tissue Anchor, 6mm x 12mm

Medshape, Inc.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: M970150000061208
• NIH Device Record Key: 8918c736-c291-49a9-b829-d44e5c8f35f6
• Commercial Distribution Discontinuation: 2023-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Eclipse
• Version Model Number: 1500-00-0612
• Company DUNS: 601306413
• Company Name: Medshape, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M970150000061208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123350

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-06-27
• Device Publish Date: 2015-09-22

On-Brand Devices [Eclipse]

• M97015000200001: Universal Tenodesis Disposable Procedure Pack
• M9701500020000: Universal Tenodesis Disposable Procedure Pack
• M97023000109008: Procedure Pack, 9.0MM Sterile Cannulated Drill/Reamer
• M9701500010900: Procedure Pack, 9.0MM Sterile Cannulated Drill/Reamer
• M97023000108007: Procedure Pack, 8.0MM Sterile Cannulated Drill/Reamer
• M9701500010800: Procedure Pack, 8.0MM Sterile Cannulated Drill/Reamer
• M97023000107006: Procedure Pack, 7.0MM Sterile Cannulated Drill/Reamer
• M9701500010700: Procedure Pack, 7.0MM Sterile Cannulated Drill/Reamer
• M97023000106005: Procedure Pack, 6.0MM Sterile Cannulated Drill/Reamer
• M9701500010600: Procedure Pack, 6.0MM Sterile Cannulated Drill/Reamer
• M97023000105509: Procedure Pack, 5.5MM Sterile Cannulated Drill/Reamer
• M9701500010550: Procedure Pack, 5.5MM Sterile Cannulated Drill/Reamer
• M97023000105004: Procedure Pack, 5.0MM Sterile Cannulated Drill/Reamer
• M9701500010500: Procedure Pack, 5.0MM Sterile Cannulated Drill/Reamer
• M97023000204509: Procedure Pack, 4.5MM Sterile Cannulated Drill/Reamer
• M9701500010450: Procedure Pack, 4.5MM Sterile Cannulated Drill/Reamer
• M97015000104004: Procedure Pack, 4MM Sterile Cannulated Drill/Reamer
• M9701500010400: Procedure Pack, 4MM Sterile Cannulated Drill/Reamer
• M970150000092000: ECLIPSE Soft Tissue Anchor, 9mm x 20mm
• M970150000091500: ECLIPSE Soft Tissue Anchor, 9mm x 15mm
• M970150000082009: ECLIPSE Soft Tissue Anchor, 8mm x 20mm
• M970150000081200: ECLIPSE Soft Tissue Anchor, 8mm x 12mm
• M970150000072008: ECLIPSE Soft Tissue Anchor, 7mm x 20mm
• M970150000071209: ECLIPSE Soft Tissue Anchor, 7mm x 12mm
• M970150000062007: ECLIPSE Soft Tissue Anchor, 6mm x 20mm
• M970150000061208: ECLIPSE Soft Tissue Anchor, 6mm x 12mm
• M970150000052006: ECLIPSE Soft Tissue Anchor, 5mm x 20mm
• M970150000051207: ECLIPSE Soft Tissue Anchor, 5mm x 12mm
• M970150000041700: ECLIPSE Soft Tissue Anchor, 4mm x 17mm
• M970150000041004: ECLIPSE Soft Tissue Anchor, 4mm x 10mm