Saffron 520350

GUDID 05708932757430

Anchor

Coloplast A/S

Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 05708932757430
• NIH Device Record Key: b867a7d7-f32e-42a7-9afe-790052be6ecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saffron
• Version Model Number: 520350
• Catalog Number: 520350
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• 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)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932757430 [Package]; Contains: 05708932757690; Package: Retail Box [12 Units]; In Commercial Distribution
GS1	05708932757690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220420

FDA Product Code

• PBQ: Fixation, non-absorbable or absorbable, for pelvic use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-19
• Device Publish Date: 2022-09-09

On-Brand Devices [Saffron]

• 05708932757430: Anchor
• 05708932757423: Fixation Tool