Digitex 52025

GUDID 05708932440134

Suture Delivery Device

Coloplast A/S

Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use

• Primary Device ID: 05708932440134
• NIH Device Record Key: b252c5aa-745c-4997-9cda-dc68c9cca74d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digitex
• Version Model Number: 52025
• Catalog Number: 52025
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• 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

• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932440127 [Primary]
GS1	05708932440134 [Package]; Contains: 05708932440127; Package: Retail Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093112

FDA Product Code

• HCF: INSTRUMENT, LIGATURE PASSING AND KNOT TYING

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: 2020-02-06
• Device Publish Date: 2015-10-28

On-Brand Devices [Digitex]

• 05708932440219: Suture Cartridge with Needle - Polypropylene Monofiliment
• 05708932440189: Suture Cartridge with Needle - Polypropylene Monofiliment
• 05708932504089: Absorbable Suture Cartridge with Needle - Polyglycolic Acid Coated
• 05708932504058: Absorbable Suture Cartridge with Needle - Polyglycolic Acid Coated
• 05708932504027: Absorbable Suture Cartridge with Needle - Polydioxanone
• 05708932503990: Absorbable Suture Cartridge with Needle - Polydioxanone
• 05708932440134: Suture Delivery Device