SURGICAL KIT

Basic Information

• Brand Name: SURGICAL KIT
• Primary DI: D7702694543
• Version / Model: ZGS-L-50-INT
• Catalog Number: ZGS-L-50-INT
• Company Name: SWEDEN & MARTINA SPA
• Labeler DUNS: 433815198
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-29
• Public Version: 1
• Public Version Date: 2025-05-07
• Public Version Status: New
• Public Device Record Key: 838406ea-a0ff-4663-92ab-c3962a395e1f

Device Description

SURGICAL KIT PRAMA GS 5.0

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7702694543	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K222640	000