FASTIN ORTHOCORD 222991

GUDID 10886705008698

FASTIN RC w/ORTHOCORD w/Needles Titanium Anchor with two Number 2 ORTHOCORD Braided Composite Sutures, 36 Inches (91cm), Violet and Blue, each armed with 2 MO-7 needles 5.0mm

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705008698
• NIH Device Record Key: e0c866f1-a9b1-41b4-b916-3474139b6c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FASTIN ORTHOCORD
• Version Model Number: 222991
• Catalog Number: 222991
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705008698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041075

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: 5
• Public Version Date: 2023-12-22
• Device Publish Date: 2015-09-01

On-Brand Devices [FASTIN ORTHOCORD]

• 10886705008728: FASTIN RC w/ORTHOCORD Titanium Anchor with two Number 2 ORTHOCORD Braided Composite Sutures, 36
• 10886705008711: FASTIN RC w/ORTHOCORD Titanium Anchor with two Number 2 ORTHOCORD Braided Composite Sutures, 36
• 10886705008704: FASTIN RC w/ORTHOCORD w/Needles Titanium Anchor with two Number 2 ORTHOCORD Braided Composite Su
• 10886705008698: FASTIN RC w/ORTHOCORD w/Needles Titanium Anchor with two Number 2 ORTHOCORD Braided Composite Su