FDA.report

NA

Primary DI
00763000479336
Brand
NA
Company
MEDTRONIC, INC.
Model
TM90P01
Device description
COMMUNICATOR TM90P01 US EMAN
Published
2025-09-05
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
EZWStimulator, electrical, implantable, for incontinence

Product Code Classifications

CodeDeviceSpecialtyClass
EZWStimulator, Electrical, Implantable, For IncontinenceGastroenterology, Urology3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000479336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000479336007630004793367630004793360763000479336

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature-35 Degrees Celsius58 Degrees Celsius
Handling Environment Temperature-31 Degrees Fahrenheit136 Degrees Fahrenheit

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
true
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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00763000810627NACB11Z63R2022-12-23
00763000811723NABB12A02R2022-12-26
00763000811754NABB7H85R262022-12-26
00763000811785NABB12A46R12022-12-26
00763000812126NAHY7W39R352022-12-31
00763000812133NABB12A69R12022-12-31
00763000812157NACB9E90R62022-12-31
00763000823580NAHY11W68R32023-01-14
00763000823597NAHY11N74R142023-01-14
00763000823795NAHY12A49R12023-01-15

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