TITAN Standard Power Unit

Basic Information

• Brand Name: TITAN Standard Power Unit
• Primary DI: 00851677007096
• Version / Model: SPU01
• Company Name: STANDARD BARIATRICS, INC
• Labeler DUNS: 091278068
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-18
• Public Version: 1
• Public Version Date: 2021-08-26
• Public Version Status: New
• Public Device Record Key: ec715e27-f593-4221-badb-d0088f06c849

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
59871	Endoscopic manual linear cutting stapler, single-use	A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851677007096	GS1

Premarket Submissions

Submission Number	Supplement Number
K210278	000