FDA.report

Plasdent

Primary DI
D832PAPF22
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
PAP-F2
Catalog number
PAP-F2
Device description
Tray Paper, F, 5" X 8", Blue
Published
2022-03-24
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
true

Related Records

Product Codes

CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D832PAPF22PackageHIBCC6In Commercial Distribution
D832PAPF21PrimaryHIBCC0
D832PAPF20Unit of UseHIBCC0

GMDN Terms

TermDefinition
Instrument tray cover, single-useA flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
190377184
Device count
1000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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D8323100B0FINE FLOSSII3100B3100B2025-06-02
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D832TSTSA0ACUTIPS TST-SATST-SA2024-08-27
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D832IITKAVOT0PlasdentIIT-KAVO-TIIT-KAVO-T2024-07-30
D832IITNSK0PlasdentIIT-NSKIIT-NSK2024-07-30
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