FDA.reportPublic FDA data

MIXPAC Protective Sleeve

Primary DI
07350069420770
Brand
MIXPAC Protective Sleeve
Company
Minitube AB
Model
5 ml
Catalog number
PRS 701-03
Device description
MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the dentist, staff and patient against cross-contamination and infectious disease during clinical use.
Published
2022-10-03
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
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
07350069421777PrimaryGS10
07350069420770Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069421777073500694217777350069421777
07350069420770073500694207707350069420770

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
300
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
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
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
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