SU-VEID

Basic Information

• Brand Name: SU-VEID
• Primary DI: 07290018896235
• Version / Model: 18103300
• Catalog Number: 18103300
• Company Name: ANGIE TECHNOLOGIES LTD
• Labeler DUNS: 600634887
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-23
• Public Version: 1
• Public Version Date: 2021-05-31
• Public Version Status: New
• Public Device Record Key: e20b58a5-8018-4a50-8c7a-b087ee68ad92

Device Description

Carton of 16 boxes (DI# 07290018896136) of 30 SU-VEID units each (DI# 07290018896037) - for a total of 480 SU-VEID units per carton.

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRF	Cleaner, Air, Medical Recirculating	General Hospital	880.5045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58340	Rib/rib cage internal fixation/bracing system bracing bar	A non-sterile implantable device intended to be used with rib grip/anchor implants either for internal fixation of a fracture or to bridge a deficit in the rib cage. It is typically a thin bar (approximately 20 cm long), with or without serrations, made of metal [e.g., titanium (Ti)]. It can be surgically removed when required or remain in situ. This device must be sterilized prior to use.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290018896235	GS1

Premarket Submissions

Submission Number	Supplement Number
K993995	000