FDA.reportPublic FDA data

Plasdent

Primary DI
D832IC210130
Brand
Plasdent
Company
PLASDENT CORPORATION
Model
IC-21013
Catalog number
IC-21013
Device description
Custom Camera Sleeves for Digital Doc, Iris
Published
2022-08-26
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

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201604000Plasdent Disposable Barrier Sleeves and Barrier FilmPlasdent Corporation2020-12-23PEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D832IC210131PrimaryHIBCC0
D832IC210130Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190377184
Device count
500
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D832MTXA15021PlasdentMTXA-1502MTXA-15022026-06-04
D832MTXA15031PlasdentMTXA-1503MTXA-15032026-06-04
D832BLT100501PlasdentBLT-100-50BLT-100-502026-05-28
D832BEE0001PlasdentBEE-000BEE-0002026-05-06
D832BEE0011PlasdentBEE-001BEE-0012026-05-06
D832BEE0021PlasdentBEE-002BEE-0022026-05-06
D832906CDG20Plasdent906CDG2906CDG22026-05-01
D832906CDG30Plasdent906CDG3906CDG32026-05-01
D832BLT1011PlasdentBLT-101BLT-1012026-05-01
D832BLT2001PlasdentBLT-200BLT-2002026-05-01
D832BLT2011PlasdentBLT-201BLT-2012026-05-01
D832BLT3001PlasdentBLT-300BLT-3002026-05-01
D832BLT3011PlasdentBLT-301BLT-3012026-05-01
D832BLT3021PlasdentBLT-302BLT-3022026-05-01
D832BLT4181PlasdentBLT-418BLT-4182026-05-01
D832BLT4201PlasdentBLT-420BLT-4202026-05-01
D832BLT4211PlasdentBLT-421BLT-4212026-05-01
D832BLT4221PlasdentBLT-422BLT-4222026-05-01
D832BLT4231PlasdentBLT-423BLT-4232026-05-01
D832BLT4251PlasdentBLT-425BLT-4252026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456214459JMUJMU DENTAL, INCPEM2026-07-10
00840456214466JMUJMU DENTAL, INCPEM2026-07-10
00840456214473JMUJMU DENTAL, INCPEM2026-07-10
00840456214480JMUJMU DENTAL, INCPEM2026-07-10
00840456214497JMUJMU DENTAL, INCPEM2026-07-10
00840456214503JMUJMU DENTAL, INCPEM2026-07-10
00840456217931JMUJMU DENTAL, INCPEM2026-07-10
00840456217948JMUJMU DENTAL, INCPEM2026-07-10
00840456217955JMUJMU DENTAL, INCPEM2026-07-10
00840456217962JMUJMU DENTAL, INCPEM2026-07-10
00840456217979JMUJMU DENTAL, INCPEM2026-07-10
00840456217986JMUJMU DENTAL, INCPEM2026-07-10
00840456214305JMUJMU DENTAL, INCPEM2026-07-06
00840456214312JMUJMU DENTAL, INCPEM2026-07-06
00840456214329JMUJMU DENTAL, INCPEM2026-07-06
00840456214336JMUJMU DENTAL, INCPEM2026-07-06
00840456214343JMUJMU DENTAL, INCPEM2026-07-06
00840456214350JMUJMU DENTAL, INCPEM2026-07-06
00840456214367JMUJMU DENTAL, INCPEM2026-07-06
00840456214374JMUJMU DENTAL, INCPEM2026-07-06
00840456214381JMUJMU DENTAL, INCPEM2026-07-06
00840456214398JMUJMU DENTAL, INCPEM2026-07-06
00840456214404JMUJMU DENTAL, INCPEM2026-07-06
00840456214411JMUJMU DENTAL, INCPEM2026-07-06
00840456214428JMUJMU DENTAL, INCPEM2026-07-06
00840456214435JMUJMU DENTAL, INCPEM2026-07-06
00840456214442JMUJMU DENTAL, INCPEM2026-07-06
00840456215265JMUJMU DENTAL, INCPEM2026-07-06
00840456215746JMUJMU DENTAL, INCPEM2026-07-06
00840456217184JMUJMU DENTAL, INCPEM2026-07-06