LUPINE ORTHOCORD 210712

GUDID 10886705001101

LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA Absorbable Anchor, with dual size 2 (5 metric) braided composite suture, violet and blue, 36 Inches (91cm). Size 2 (5 metric) eyelet loop.

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705001101
• NIH Device Record Key: b3a3f4b6-1a6e-41bd-bbec-f5283ac316ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUPINE ORTHOCORD
• Version Model Number: 210712
• Catalog Number: 210712
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705001101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040827

FDA Product Code

• GAT: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

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: 2024-01-09
• Device Publish Date: 2015-09-01

On-Brand Devices [LUPINE ORTHOCORD]

• 10886705001101: LUPINE BR Anchor W/DS ORTHOCORD TCP/PLGA Absorbable Anchor, with dual size 2 (5 metric) braided
• 10886705001095: LUPINE BR ANCHOR w/ORTHOCORD TCP/PLGA Absorbable Anchor, size 2 (5 metric) braided composite sut