FDA.report

NA

Primary DI
07630031728425
Brand
NA
Company
Institut Straumann AG
Model
Non-invasive Instruments
Catalog number
025.0029
Device description
SC Polishing Aid, L 16mm, stainless steel
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630031728425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630031728425076300317284257630031728425

GMDN Terms

TermDefinition
Orthopaedic cement ultrasonic surgical system handpiece tip, single-useA removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut orthopaedic cement upon contact during an orthopaedic surgical procedure (e.g., revision hip arthroplasty); it is not intended to cut body tissues. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for cement debris aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.

Device Sizes

TypeValueUnit
Length16Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags

DUNS number
483599259
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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07630031772862NAsurgically Invasive Instruments044.797S2026-03-04
07630031772879NAsurgically Invasive Instruments066.1101S2026-03-04

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