SubQ It! Bioabsorbable Skin Closure System 412010

GUDID 10867469000234

SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.

OPUS KSD, INC.

Skin stapler/staple, bioabsorbable

• Primary Device ID: 10867469000234
• NIH Device Record Key: e62c55cb-b091-43cc-802e-cccfa5d920d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SubQ It! Bioabsorbable Skin Closure System
• Version Model Number: SU-10
• Catalog Number: 412010
• Company DUNS: 965571289
• Company Name: OPUS KSD, INC.
• 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: true
• 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: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com
• Phone: 3399338811
• Email: chuck@subq-it.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867469000237 [Primary]
GS1	10867469000234 [Package]; Contains: 00867469000237; Package: Shelf Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131563

FDA Product Code

• QQS: Stapler, Skin

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: 2025-03-17
• Device Publish Date: 2025-03-07

On-Brand Devices [SubQ It! Bioabsorbable Skin Closure System]

• 10867469000227: SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with
• 10867469000234: SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with