FDA.report

Multi unit plastic sleeve

Primary DI
07290018435441
Brand
Multi unit plastic sleeve
Company
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
Model
Alef
Catalog number
MUPS
Published
2024-01-24
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
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290018435441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290018435441072900184354417290018435441

GMDN Terms

TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
531825934
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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07290019897620Ratchet click driver longRPRPRCDL2024-01-30
07290019897675Implant hand driver shortALIHDS2024-01-30
07290019897019Implant hand driver longRPRPIHDL2024-01-29
07290019897026Motor mount click driver longTPTPMCDL2024-01-29
07290019897071Motor mount click driver short NPNPMCDS2024-01-29
07290019897125Motor mount click driver longNPNPMCDL2024-01-29
07290019897156Guided ratchet driver longALGDRIML2024-01-29
07290019897170Motor mount click driver short RPRPMCDS2024-01-29
07290019897200Guided ratchet driver shortALGDRIMS2024-01-29
07290019897224Motor mount click driver longRPRPMCDL2024-01-29
07290019897255Guided ratchet driver longTPGTPDRIML2024-01-29
07290019897279Ratchet click driver shortALRCDS2024-01-29
07290019897309Guided ratchet driver shortTPGTPDRIMS2024-01-29
07290019897323Ratchet click driver longALRCDL2024-01-29
07290019897354Guided Ti SleeveAL TPGDSS2024-01-29
07290019897378Ratchet click driver shortTPTPRCDS2024-01-29
07290019897385Implant Drivers for Motor long 28mmAlefDMIL2024-01-29
07290019897408Guided Fixation pinsAL TPGDFIX2024-01-29
07290019897422Ratchet click driver longTPTPRCDL2024-01-29
07290019897439Implant Drivers for Motor short 22mmAlefDMIS2024-01-29

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08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
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08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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