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Invasive Accessories And Instruments

FDA UDI

Class I (US FDA UDI)

by Rhein 83 Srl

Identity

Trade Name
INVASIVE ACCESSORIES AND INSTRUMENTS FDA UDI
Generic Name
Dental implant holding endpiece, reusable FDA UDI
Device Name
REUSABLE and STERILIZABLE device designed to remove a broken prosthetic screw from the inside of a dental implant. FDA UDI
Model / Reference
ESTRATTORE IMP. REPLACE Select ø 3,5 FDA UDI
Description
REUSABLE and STERILIZABLE device designed to remove a broken prosthetic screw from the inside of a dental implant. FDA UDI

Identifiers

Catalog Number
680RPS35 FDA UDI
Primary DI / UDI-DI
D821680RPS35 FDA UDI
FDA Product Code
DZA FDA UDI
GMDN Term
Dental implant holding endpiece, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4130 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Invasive Accessories And Instruments by Rhein 83 Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhein 83 Srl

Sources (1)

  • FDA UDI 0a28c705-3730-4554-a5ba-d109539f927a 35 fields · synced May 31, 2026