FDA.report

ANALOG HE Ø4.1MM HEX. 2.95

Primary DI
07899995267986
Brand
ANALOG HE Ø4.1MM HEX. 2.95
Company
Sin Sistema de Implante Nacional S/A
Model
AN 4100EC
Catalog number
AN 4100EC
Device description
ANALOG HE Ø4.1MM HEX. 2.95
Published
2023-09-05
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
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899995267986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899995267986078999952679867899995267986

GMDN Terms

TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
904569092
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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