FDA.report

FLAT TIP OSTEOTOME FOR SHELTA

Primary DI
D7701237113
Brand
FLAT TIP OSTEOTOME FOR SHELTA
Company
SWEDEN & MARTINA SPA
Model
SH-OS-500-150-PP
Catalog number
SH-OS-500-150-PP
Device description
FLAT TIP OSTEOTOME FOR SHELTA IMPLANTS D.5.00 H.15 MM
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7701237113PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
844.862.7846info.us@sweden-martina.com

Regulatory Flags

DUNS number
433815198
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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