NA

Basic Information

• Brand Name: NA
• Primary DI: 07630031717634
• Version / Model: surgically Invasive Instruments
• Catalog Number: 040.457S
• Company Name: Institut Straumann AG
• Labeler DUNS: 483599259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 2
• Public Version Date: 2023-09-19
• Public Version Status: Update
• Public Device Record Key: 627f30bd-8a15-4dfd-887c-f453ee723177

Device Description

Refill Package, f. Drill Stop Set, type D, f.drill short 6 mm/long 10 mm, for Ø 3.3 - 4.8 implants, contents 040.453S

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: Yes
• 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
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45148	Dental/maxillofacial surgical procedure kit, non-medicated, single-use	A collection of various sterile 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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630031717634	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.3	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight