FDA.report

RINN®

Primary DI
D0035402000
Brand
RINN®
Company
Dentsply International Inc.
Model
540200
Catalog number
540200
Device description
RINN® Snap-A-Ray® Film Holder
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EGZHolder, film, x-ray

Product Code Classifications

CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0035402001PrimaryHIBCC0
D0035402000Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Sterilize before each use per Instructions for Use

Sterilization Methods

Method

Regulatory Flags

DUNS number
795572718
Device count
3
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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