FDA.reportPublic FDA data

OdneClean

Primary DI
07649988629310
Brand
OdneClean
Company
Minitube AB
Model
A-0006
Catalog number
A-0006
Device description
OdneClean barrier sleeves, 100pcs per box.
Published
2024-06-01
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
07649988629310PrimaryGS10
07649988629327Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07649988629310076499886293107649988629310
07649988629327076499886293277649988629327

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
775295061
Device count
100
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
07350069421845VALO™ Barrier SleevesVALO X 600 Barrier Sleeves Refill58982024-05-01
07350069421852VALO™ Barrier SleevesVALO Cordless 600 Barrier Sleeves Refill 58962024-05-01
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
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