FDA.report

Plasdent

Primary DI
D8324040CT0
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
4040-CT
Catalog number
4040-CT
Device description
Pure Cotton Spunlace Sponges, 4" X 4", Non-Sterile, 4-Ply, 40g, Non-Woven
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
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8324040CT1PrimaryHIBCC0
D8324040CT0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Petrolatum non-woven gauze padA sterile, non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
190377184
Device count
2000
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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D8323100T0FINE FLOSSII3100T3100T2025-06-02
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D832TSTSA0ACUTIPS TST-SATST-SA2024-08-27
D832IITBIENAIR0PlasdentIIT-BIENAIRIIT-BIENAIR2024-07-30
D832IITKAVOT0PlasdentIIT-KAVO-TIIT-KAVO-T2024-07-30
D832IITNSK0PlasdentIIT-NSKIIT-NSK2024-07-30
D832IITU10PlasdentITT-U1ITT-U12024-07-30

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20665973020918DukalDukal LLCNAB2026-01-30
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00723896029640Practicon® Premium 4x4 Non-Woven Sponges 200/PackPRACTICON, INC.NAB2026-01-07
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