FDA.reportPublic FDA data

Premium Plus

Primary DI
D125133L2
Brand
Premium Plus
Company
Premium Plus (Dongguan) Limited
Model
133L
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
D125133L6PackageHIBCC10In Commercial Distribution
D125133L8PackageHIBCC4In Commercial Distribution
D125133L2PrimaryHIBCC0
D125133L0Unit 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
D125100B2Premium Plus100B2026-05-22
D125100C2Premium Plus100C2026-05-22
D1251012Premium Plus1012026-05-22
D1251022Premium Plus1022026-05-22
D1251032Premium Plus1032026-05-22
D125104L2Premium Plus104L2026-05-22
D125104S2Premium Plus104S2026-05-22
D1251062Premium Plus1062026-05-22
D1251072Premium Plus1072026-05-22
D1251082Premium Plus1082026-05-22
D1251092Premium Plus1092026-05-22
D1251112Premium Plus1112026-05-22
D1251122Premium Plus1122026-05-22
D1251132Premium Plus1132026-05-22
D1251142Premium Plus1142026-05-22
D1251182Premium Plus1182026-05-22
D1251192Premium Plus1192026-05-22
D125123L2Premium Plus123L2026-05-22
D125123M2Premium Plus123M2026-05-22
D125123S2Premium Plus123S2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D125100B2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125100C2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251012Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251022Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251032Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125104S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251062Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251072Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251082Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251092Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251112Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251122Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251132Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251142Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251182Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251192Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123M2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125123XL2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251252Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125125SS2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251282Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251292Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125133S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135L2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D125135S2Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22
D1251362Premium PlusPremium Plus (Dongguan) LimitedPEM2026-05-22