← Back to catalogue

Shatkin FIRST

FDA UDI

Class I (US FDA UDI)

by Aseptico, Inc.

Identity

Trade Name
Shatkin FIRST FDA UDI
Generic Name
Dental surgical power tool motor, electric FDA UDI
Device Name
Implant, Endo and Oral Surgery System FDA UDI
Model / Reference
AEU-7000E-SFI-70V FDA UDI
Description
Implant, Endo and Oral Surgery System FDA UDI

Identifiers

Primary DI / UDI-DI
10817417021248 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Dental surgical power tool motor, electric FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental surgical power tool motor, electric

Shatkin FIRST by Aseptico, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental surgical power tool motor, electric.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Aseptico, Inc.

Sources (1)

  • FDA UDI 35d07f2f-ac8d-4c26-818b-c9b2e7af777b 36 fields · synced May 30, 2026