FDA.report

NA

Primary DI
07630031756671
Brand
NA
Company
Institut Straumann AG
Model
Wax-up sleeves
Catalog number
025.2903-04
Device description
NC Wax-up sleeve L 15.1 mm, PEEK
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630031711779PrimaryGS10
07630031756671Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630031711779076300317117797630031711779
07630031756671076300317566717630031756671

GMDN Terms

TermDefinition
Dental precision attachment simulator/analog, single-useA device intended to be used to imitate or copy a dental precision attachment, or element that is part of a precision attachment, during fabrication of a final dental prosthesis (e.g., denture, crown, bridge) in the dental laboratory. It may be an instrument designed to reproduce the position, shape, and dimensions of a precision attachment, or it may be a copy of a precision attachment designed to enable fabrication of, or correct incorporation of, the final precision attachment in the dental prosthesis. This is a single-use device.

Device Sizes

TypeValueUnit
Length15.1Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
483599259
Device count
4
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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