FDA.report

Midas Rex®

Primary DI
00613994572967
Brand
Midas Rex®
Company
MEDTRONIC POWERED SURGICAL SOLUTIONS
Model
EA650
Device description
ACCY EA650 POWER CORD 6 METER
Published
2016-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications

CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613994572967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994572967006139945729676139945729670613994572967

GMDN Terms

TermDefinition
Multi-purpose surgical power tool system, line-poweredAn assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
098308849
Device count
1
DM exempt
false
Premarket exempt
false
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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