GRYPHON PERMACORD 223149

GUDID 10886705024742

GRYPHON PEEK DS ANCHOR w/ PERMACORD PEEK Anchor (1) Blue (1) White/Black, Size 2 (5 metric) PERMACORD Suture, 36 Inches (91cm)

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705024742
• NIH Device Record Key: 641f0239-faaf-4ca2-8b61-605ab8256421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRYPHON PERMACORD
• Version Model Number: 223149
• Catalog Number: 223149
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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

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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705024742 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141259

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

On-Brand Devices [GRYPHON PERMACORD]

• 10886705024742: GRYPHON PEEK DS ANCHOR w/ PERMACORD PEEK Anchor (1) Blue (1) White/Black, Size 2 (5 metric) PERM
• 10886705024636: GRYPHON PEEK ANCHOR w/ PERMACORD PEEK Anchor (1) Blue, Size 2 (5 metric) PERMACORD Suture, 36 In
• 10886705024629: GRYPHON P BR ANCHOR w/ PERMACORD TCP/PLGA Absorbable Anchor (1) Blue, Size 2 (5 metric) PERMACOR
• 10886705024612: GRYPHON P BR DS ANCHOR w/ PERMACORD TCP/PLGA Absorbable Anchor (1) Blue (1) White/Black, Size 2