Eclipse

GUDID M97015000005120

ECLIPSE, 5MM X 12MM

Medshape, Inc.

Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: M97015000005120
• NIH Device Record Key: abbd84f2-6036-4aec-84bf-24a29983cacc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse
• Version Model Number: 1500-00-0512
• 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	M97015000005120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123350

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

[M97015000005120]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2025-07-17
• Device Publish Date: 2017-05-19

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
• M97015000008200: ECLIPSE, 8MM X 20MM
• M97015000007200: ECLIPSE, 7MM X 20MM
• M97015000006200: ECLIPSE, 6MM X 20MM
• M97015000005200: ECLIPSE, 5MM X 20MM
• M97015000005120: ECLIPSE, 5MM X 12MM
• M97015000004170: ECLIPSE, 4MM X 17MM
• M97015000004100: ECLIPSE, 4MM X 10MM
• M9702300010900: Acorn Reamer, 9.00mm
• M9702300010800: Acorn Reamer, 8.00mm
• M9702300010700: Acorn Reamer, 7.00mm
• M9702300010600: Acorn Reamer, 6.00mm
• M9702300010550: Acorn Reamer, 5.50mm
• M9702300010500: Acorn Reamer, 5.00mm
• M97015000400000: Tendon Spear, ExoShape Tenodesis
• M97015000009200: ECLIPSE, 9MM X 20MM