FDA.reportPublic FDA data

Premium Plus

Primary DI
D125133S2
Brand
Premium Plus
Company
Premium Plus (Dongguan) Limited
Model
133S
Device description
Disposable Barrier Sleeves
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K220662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220662000Disposable Barrier SleevesPremium Plus (Dongguan) Limited2022-05-11PEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D125133S6PackageHIBCC10In Commercial Distribution
D125133S8PackageHIBCC4In Commercial Distribution
D125133S2PrimaryHIBCC0
D125133S0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassetteA device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.

Regulatory Flags#

DUNS number
541637603
Device count
500
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D12518N4012Premium Plus18-N4012026-06-09
D12518N4022Premium Plus18-N4022026-06-09
D12518N4032Premium Plus18-N4032026-06-09
D12518N4042Premium Plus18-N4042026-06-09
D12518N4052Premium Plus18-N4052026-06-09
D12518S4012Premium Plus18-S4012026-06-09
D12518S4022Premium Plus18-S4022026-06-09
D12518S4032Premium Plus18-S4032026-06-09
D12518T4012Premium Plus18-T4012026-06-09
D12518T4022Premium Plus18-T4022026-06-09
D12518T4032Premium Plus18-T4032026-06-09
D1254334Premium Plus4332026-06-09
D1254344Premium Plus4342026-06-09
D1254354Premium Plus4352026-06-09
D1254364Premium Plus4362026-06-09
D1254374Premium Plus4372026-06-09
D1254384Premium Plus4382026-06-09
D1254394Premium Plus4392026-06-09
D1254404Premium Plus4402026-06-09
D1254514Premium Plus4512026-06-09

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