N/A

Primary DI
00763000650551
Brand
N/A
Company
MEDTRONIC, INC.
Model
TM91D0
Device description
COMMUNICATOR TM91D0 US EMANUAL
Published
2024-01-22
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

Contact Domains

Product Codes

CodeName
MHYStimulator, electrical, implanted, for parkinsonian tremor

Product Code Classifications

CodeDeviceSpecialtyClass
MHYStimulator, Electrical, Implanted, For Parkinsonian TremorUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000650551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000650551007630006505517630006505510763000650551

GMDN Terms

TermDefinition
Multiple active implantable device programmerAn external, portable, non-dedicated, electrically-powered device intended to change, noninvasively (i.e., wirelessly), the operating parameters (programs) of multiple types of implanted electronic devices (e.g., multiple types of pulse generators); it may in addition program the external trial device used prior to the implanted one. It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It typically also provides historic and/or current information regarding the performance of the implant.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
796986144
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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