FDA.report

MIS

Primary DI
07290109013930
Brand
MIS
Company
MIS Implants Technologies Ltd.
Model
MG-P0824
Catalog number
MG-P0824
Device description
MGUIDE universal pilot drill dia.2.40 L 8mm
Published
2022-11-16
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
false

Related Records

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290109013930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290109013930072901090139307290109013930

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
514576057
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07290118506034MIS C1C1-X103302026-01-20

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