RINN® 559907

GUDID D0035599070

RINN® XCP-DS FIT® #0 PA

Dentsply International Inc.

Dental x-ray film holder, reusable

• Primary Device ID: D0035599070
• NIH Device Record Key: 38f2c1f2-cf1f-448c-99e2-d7b178a65112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RINN®
• Version Model Number: 559907
• Catalog Number: 559907
• Company DUNS: 795572718
• Company Name: Dentsply International Inc.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use
• Special Storage Condition, Specify: Between 0 and 0 *Sterilize before each use per Instructions for Use

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0035599070 [Unit of Use]
HIBCC	D0035599071 [Primary]

FDA Product Code

• EGZ: Holder, film, x-ray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-02
• Device Publish Date: 2022-11-24

On-Brand Devices [RINN®]

• D0035599171: XCP-DS FIT® Complete OEM Kit. Contains: 1 XCP-ORA® Arm and Ring, 1 XCP-DS FIT® Endo Arm & Rin
• D0035599121: XCP-DS FIT® Universal Sensor Holder. Contains: 1 XCP-ORA Arm & Ring, 1 XCP-DS FIT Endo Arm & Ri
• D0035599111: XCP-DS FIT® Universal Sensor Holder. Trial Pack Contains: 1 XCP-ORA® Arm and Ring, 2 Biteblock
• D0035599101: XCP-DS Fit® Hygiene Kit. Contains: 4 Arms and Rings (1 Anterior, 2 Posterior, 1 Bitewing); 8 XC
• D0035599091: XCP-DS Fit® Hygiene Kit. Contains: 1 XCP-ORA® Arm and Ring, Endo Arm and Ring, 10 XCP-DS FIT®
• D0035599081: XCP-DS Fit® Endodontic Kit. Contains: 1 Endo Arm and Ring, 2 XCP-DS FIT® Endo Biteblocks.
• D0035599001: XCP-DS Fit® Hygeine Kit. Contains: 1 XCP-ORA® Arm and Ring, 8 XCP-DS FIT® Biteblocks (2 each:
• D0035562711: XCP-ORA® Owandy Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® 6 Biteblocks (4 Biteblocks on
• D0035561711: XCP-ORA® Owandy Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® Kodak 4 Biteblocks (1 Vertica
• D0035560711: XCP-ORA® Owandy Kit. Contains: XCP-ORA® 1 Arm and Ring, XCP-DS® 28 Biteblocks (4 Dexis Anteri
• D0035549161: XCP-QT® Dexis Trial Pack. Contains: 4 Bases, 2 Bitetabs, 2 Bitewings, 4 Bulk Sensor Covers.
• D0035549131: XCP-QT® #1/#2 Sample Pack. Contains: 4 Bases, 2 Bitetabs, 2 Bitewings, 4 Bulk Sensor Covers.
• D0035549121: XCP-QT® #2 Sample Pack. Contains: 5 Bases, 5 Bitetabs, 5 Bitewings, 5 Bulk Sensor Covers.
• D0035549111: XCP-QT® #1 Sample Pack. Contains: 5 Bases, 5 Bitetabs, 5 Bitewings, 5 Bulk Sensor Covers.
• D0035549051: XCP-QT® Universal Disposable Sensor Holder. Contains: 2 XCP-ORA® Arms and Rings, XCP-QT 100 Bi
• D0035549001: XCP-QT® Universal Disposable Sensor Holder. Contains: 2 XCP-ORA® Arms and Rings, 25 Size #1 Ba
• D0035547821: XCP-ORA® Toshiba #2. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® EVA Plus: 2 Horizontal Poster
• D0035547811: XCP-ORA® Toshiba #1. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® EVA Plus: 2 Horizontal Poster
• D0035538711: XCP-DS® Prosensor Kit. Contains: 8 Vertical Bitewings. XCP-DS® EVA: Plus 4 Horizontal Posterio
• D0035530711: XCP-ORA® RVG 6100. Contains: XCP-DS® Kodak 8 Horizontal Bitewings with Biteblocks, 8 Vertical
• D0035529711: XCP-ORA® Schick Elite Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® EVA Plus 8 Anterior Bit
• D0035525711: XCP-ORA® Dexis Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® Dexis 4 Horizontal Bitewings w
• D0035525001: XCP-DS® Sensor Positioning System for DEXIS Digital Sensors Contains: XCP-DS® 10 Biteblocks (2
• D0035521601: XCP-ORA® Sirona XIOS Plus. Contains: XCP-DS® Kodak 8 Vertical Anterior Biteblocks, XCP-DS® Ko
• D0035519711: XCP-ORA® Schick CDR Kit. Contains: 1 XCP-ORA® Arm and Ring. XCP-DS® 8 Horizontal Bitewings, 8
• D0035502521: Uni-Grip® 360, Universal Sensor Holder. Contains: 100 Sensor Holders, 100 Sensor Covers, Uni-
• D0035501481: FASTabâ„¢ Bitewing Holder & Uni-Grip 360 Holder. Contains: 100 FASTabâ„¢ Bitewing Holders, 25 Un
• D0035501471: FASTabâ„¢ Bitewing Holder & Uni-Grip 360 Holder. Contains: 100 FASTabâ„¢ Bitewing Holders, 25 Un
• D0035501461: FASTabâ„¢ Bitewing Holder & Uni-Grip 360 Holder. Contains: 100 FASTabâ„¢ Bitewing Holders, 25 Un
• D0035501411: FASTabâ„¢ Bitewing Kit - Size 1.5/2. Also contains: 100 FASTabâ„¢ Bitewing Holders and 100 RinnÂ
• D0035501401: FASTabâ„¢ Bitewing Holder Kit - Size 1. Also contains: 100 FASTabâ„¢ Bitewing Holders and 100 Ri
• D0035500521: Uni-Grip® 360, Universal Sensor Holder. Contains: 50 Sensor Holders, 50 Sensor Covers
• D003550051B1: Rinn® Uni-Grip® 360 Trial Pk
• D0035499751: XCP-DS FIT® Universal Sensor Holder. Contains: Snap-A-Ray Pack, 2 XCP-ORA® Arm and Rings, 6 Bi
• D0035499711: XCP-DS FIT® Universal Sensor Holder. Contains: 1 XCP-ORA® Arm & Ring, 6 Biteblocks, 6 Bitewing
• D6475408531: UNIVERSAL COLLIMATOR
• D0035599140: Replacement Silicone Bands LONG for ANTERIOR, ANTERIOR - Thin, and HBW
• D0035599130: Replacement Silicone Bands SHORT for POSTERIOR, VBS, Endo and Size 0
• D0035599260: RINN® XCP-DS FIT® Thin Anterior Sensor Holders
• D0035599230: RINN® XCP-DS FIT® Horizontal BW Sensor Holders
• D0035599220: RINN® XCP-DS FIT® Posterior Sensor Holders
• D0035599210: RINN® XCP-DS FIT® Anterior Sensor Holders
• D0035599070: RINN® XCP-DS FIT® #0 PA
• D0035599060: RINN® XCP-DS FIT® Thin Anterior Sensor Holders
• D0035599050: RINN® XCP-DS FIT® Endo Sensor Holders
• D0035599040: RINN® XCP-DS FIT® Vertical BW Sensor Holders
• D0035599030: RINN® XCP-DS FIT® Horizontal BW Sensor Holders
• D0035599020: RINN® XCP-DS FIT® Posterior Sensor Holders
• D0035599010: RINN® XCP-DS FIT® Anterior Sensor Holders
• D0035537121: RINN® XCP-DS FIT® Carestream Kit