← Back to catalogue

PlaneAnalyser II

FDA UDI

Class I (US FDA UDI)

by zebris MEDICAL GmbH

Identity

Trade Name
PlaneAnalyser II FDA UDI
Generic Name
Facebow FDA UDI
Device Name
Opto-Electronic Face-Bow for monitoring and tracking of lower jaw movements. FDA UDI
Model / Reference
01170071 FDA UDI
Description
Opto-Electronic Face-Bow for monitoring and tracking of lower jaw movements. FDA UDI

Identifiers

Catalog Number
NA FDA UDI
Primary DI / UDI-DI
B915011700710 FDA UDI
FDA Product Code
NFS FDA UDI
GMDN Term
Facebow FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.2060 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Facebow

PlaneAnalyser II by zebris MEDICAL GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Facebow.

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
zebris MEDICAL GmbH

Sources (1)

  • FDA UDI 753c2bc7-28a9-462a-a2c6-7c0c33663f29 36 fields · synced May 30, 2026