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PlaneAnalyser II USB

FDA UDI

Class I (US FDA UDI)

by zebris MEDICAL GmbH

Identity

Trade Name
PlaneAnalyser II USB FDA UDI
Generic Name
Facebow FDA UDI
Device Name
Opto-Electronic System including Face-Bow for monitoring and tracking of lower jaw movements and accessories, USB-Version FDA UDI
Model / Reference
01570072 FDA UDI
Description
Opto-Electronic System including Face-Bow for monitoring and tracking of lower jaw movements and accessories, USB-Version FDA UDI

Identifiers

Primary DI / UDI-DI
B915015700721 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

Yes

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 USB 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

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Manufacturer

Manufacturer
zebris MEDICAL GmbH

Sources (1)

  • FDA UDI 4192e52f-06aa-4634-8f37-34d95f9fbfb9 35 fields · synced May 30, 2026