FDA.reportPublic FDA data

VALO™ Barrier Sleeves

Primary DI
07350069421845
Brand
VALO™ Barrier Sleeves
Company
Minitube AB
Model
VALO X 600 Barrier Sleeves Refill
Catalog number
5898
Device description
Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchants and other chemistry, and are highly important for keeping your VALO curing light sanitary. Barrier sleeves are available in three sizes to fit VALO™ X, VALO™ Grand, and VALO™ Corded/Cordless curing lights.Prevents direct contact between your VALO curing light and the patient’s tissuesProtects your VALO curing light from direct contact with etchants and other chemistryImportant for maintaining sanitary conditionsAvailable in three sizes
Published
2024-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K211026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211026000Minitube Dentasleeve Protective Barrier SleevesMinitube AB2021-08-03PEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350069422842PackageGS12In Commercial Distribution
07350069421845PrimaryGS10
07350069420848Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069422842073500694228427350069422842
07350069421845073500694218457350069421845
07350069420848073500694208487350069420848

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
775295061
Device count
300
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B9764488001OptiClear Sleeves4488002026-02-13
B9764488041OptiClear Sleeves4488042026-02-13
B9764488061OptiClear Sleeves4488062026-02-13
B9764488101OptiClear Sleeves4488062026-02-13
B9764488081OptiClear Sleeves4488082026-02-13
07350069421579C20 Intraoral Protective Sheaths4030622025-04-01
07350069421562C20 Intraoral Protective Sheaths4030612025-04-01
07350069420572C20 Intraoral Protective Sheaths4030622025-04-01
07350069421760MIXPAC Protective Sleeve50 mlPRS 801-032022-10-03
07350069421777MIXPAC Protective Sleeve5 mlPRS 701-032022-10-03
07350069421784MIXPAC Protective Sleeve1 mlPRS 601-032022-10-03
07350069421838VALO™ Barrier SleevesVALO Corded 600 Barrier Sleeves Refill 58972024-05-01
07350069421852VALO™ Barrier SleevesVALO Cordless 600 Barrier Sleeves Refill 58962024-05-01
07649988629310OdneCleanA-0006A-00062024-06-01
07350069422835VALO™ Barrier SleevesVALO Corded 600 Barrier Sleeves Refill 58972024-05-01
07350069422842VALO™ Barrier SleevesVALO X 600 Barrier Sleeves Refill58982024-05-01
07350069422859VALO™ Barrier SleevesVALO Cordless 600 Barrier Sleeves Refill 58962024-05-01
07350069420763MIXPAC Protective Sleeve50 mlPRS 801-032022-10-03
07350069420770MIXPAC Protective Sleeve5 mlPRS 701-032022-10-03
07350069420787MIXPAC Protective Sleeve1 mlPRS 601-032022-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840456220740JMUJMU DENTAL, INCPEM2026-07-06
00840456220757JMUJMU DENTAL, INCPEM2026-07-06
00840456220764JMUJMU DENTAL, INCPEM2026-07-06
00840456220771JMUJMU DENTAL, INCPEM2026-07-06
00840456220788JMUJMU DENTAL, INCPEM2026-07-06
06430035873371OCCLUSAL 4C KIT SCAN EXAMPaloDEx Group OyPEM2026-06-22
B9764488001OptiClear SleevesMinitube ABPEM2026-02-13
B9764488041OptiClear SleevesMinitube ABPEM2026-02-13
B9764488061OptiClear SleevesMinitube ABPEM2026-02-13
10618125192301CarinaTIDI PRODUCTS, LLCPEM2025-09-22
00618125187126VALOTIDI PRODUCTS, LLCPEM2025-08-29
00618125187133VALOTIDI PRODUCTS, LLCPEM2025-08-29