FDA.reportPublic FDA data

Plasdent

Primary DI
D832CTR021
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
CTR-02
Catalog number
CTR-02
Device description
Cotton Rolls, Non-Sterile, #2
Published
2022-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832CTR022PackageHIBCC12In Commercial Distribution
D832CTR021PrimaryHIBCC0
D832CTR020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cotton rollA non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.

Regulatory Flags#

DUNS number
190377184
Device count
2000
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832CFT11PlasdentCFT-1CFT-12026-10-13
D832FT11PlasdentFT-1FT-12026-10-13
D832SAP21PlasdentSAP-2SAP-22026-10-13
D832SAP31PlasdentSAP-3SAP-32026-10-13
D832SAPR21PlasdentSAP-R2SAP-R22026-10-13
D832SAPR31PlasdentSAP-R3SAP-R32026-10-13
D832CT10L1PlasdentCT10-LCT10-L2026-10-12
D832CT10M1PlasdentCT10-MCT10-M2026-10-12
D832CT10S1PlasdentCT10-SCT10-S2026-10-12
D832CT10XL1PlasdentCT10-XLCT10-XL2026-10-12
D832CT2L1PlasdentCT2-LCT2-L2026-10-12
D832CT2M1PlasdentCT2-MCT2-M2026-10-12
D832CT2S1PlasdentCT2-SCT2-S2026-10-12
D832CT2XL1PlasdentCT2-XLCT2-XL2026-10-12
D832CT2XXL1PlasdentCT2-XXLCT2-XXL2026-10-12
D832CT6L1PlasdentCT6-LCT6-L2026-10-12
D832CT6M1PlasdentCT6-MCT6-M2026-10-12
D832CT6S1PlasdentCT6-SCT6-S2026-10-12
D832CT6XL1PlasdentCT6-XLCT6-XL2026-10-12
D832JK10L1PlasdentJK10-LJK10-L2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D832CFT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832FT11PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAP31PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR21PlasdentPLASDENT CORPORATIONNAB2026-10-13
D832SAPR31PlasdentPLASDENT CORPORATIONNAB2026-10-13
M689HHMTG01020MiniTAC GauzeSafeguard US Operating, LLCNAB2026-10-13
00050428143117CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428339763CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
00050428343869CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNAB2026-10-10
10885380207150CurityCardinal Health 200, LLCNAB2026-10-08
10885380207167CurityCardinal Health 200, LLCNAB2026-10-08
10885380207174CurityCardinal Health 200, LLCNAB2026-10-08
50885380207202CurityCardinal Health 200, LLCNAB2026-10-08
50885380207219CurityCardinal Health 200, LLCNAB2026-10-08
50885380207226CurityCardinal Health 200, LLCNAB2026-10-08
50885380207233CurityCardinal Health 200, LLCNAB2026-10-08
50885380207240CurityCardinal Health 200, LLCNAB2026-10-08
50885380207257CurityCardinal Health 200, LLCNAB2026-10-08
06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
00810194401671AiraAIRA, LLCNAB2026-08-26
06979931947972TempoXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-08-21
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23