SubQ It! Bioabsorbable Skin Closure System 412010

GUDID 10867469000227

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: 10867469000227
• NIH Device Record Key: 0bff362f-47d2-4bf7-9896-299386826c28
• 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: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com
• Phone: 3399338811
• Email: rob@subq-it.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures above 120 degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867469000220 [Primary]
GS1	10867469000227 [Package]; Contains: 00867469000220; Package: Shelf Box [6 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: 2023-08-10
• Device Publish Date: 2023-08-02

Devices Manufactured by OPUS KSD, INC.

• 10867469000227 - SubQ It! Bioabsorbable Skin Closure System: 2023-08-10SubQ 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.
• 10867469000227 - SubQ It! Bioabsorbable Skin Closure System: 2023-08-10 SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fastene
• 10867469000210 - SubQ It!: 2019-08-06 SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler preloaded with 10 bioabsorbable fasteners, packag
• 00867469000206 - SubQ It!: 2019-08-06 SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable