SubQ It!

Basic Information

• Brand Name: SubQ It!
• Primary DI: 00867469000206
• Version / Model: 404010
• Company Name: OPUS KSD, INC.
• Labeler DUNS: 965571289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 4
• Public Version Date: 2019-08-06
• Public Version Status: Update
• Public Device Record Key: 32f021bc-02b6-4098-9d0b-a5ab76609103

Device Description

SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDW	Staple, Implantable	General, Plastic Surgery	878.4750	2
GAG	Stapler, Surgical	General Hospital	878.4740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46332	Skin stapler	A sterile hand-held surgical instrument designed for the application of skin staples to approximate free edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with staples and is intended to mechanically deliver staples with manual power. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00867469000206	GS1
Package	10867469000203	GS1	Shelf Box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131563	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius