RINN® - XCP-DS FIT® Universal Sensor Holder. Trial Pack - Dentsply International Inc.

Duns Number:795572718

Device Description: XCP-DS FIT® Universal Sensor Holder. Trial Pack Contains: 1 XCP-ORA® Arm and Ring, 2 Biteb XCP-DS FIT® Universal Sensor Holder. Trial Pack Contains: 1 XCP-ORA® Arm and Ring, 2 Biteblocks, 2 Bitewings (1 Vertical, 1 Horizontal), 50 Universal Sensor Covers.

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More Product Details

Catalog Number

-

Brand Name

RINN®

Version/Model Number

559911

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EGZ

Product Code Name

Holder, film, x-ray

Device Record Status

Public Device Record Key

c5fb2926-e29b-48f2-a1db-f9b0f445b977

Public Version Date

October 21, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTSPLY INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 57
2 A medical device with a moderate to high risk that requires special controls. 19532