FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 00763000612832 · Model: A90300 · MEDTRONIC, INC.
Product Codes
10
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
N/A
Primary DI
00763000612832
Version / Model
A90300
Company Name
MEDTRONIC, INC.
Labeler DUNS
006261481
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-19
Public Version
3
Public Version Date
2026-01-13
Public Version Status
Update
Public Device Record Key
401812fb-c597-4708-a959-884a245e3588

Device Description

SW APP A90300 RECHAGER APPLICATION V2.0

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
QRB Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
MBX Stimulator, thalamic, epilepsy, implanted
LGW Stimulator, spinal-cord, totally implanted for pain relief
QON Implanted electrical device intended for treatment of fecal incontinence
PJS Stimulator, electrical, implanted, for essential tremor
EZW Stimulator, electrical, implantable, for incontinence
MRU implanted subcortical electrical Stimulator (motor disorders)
NHL Stimulator, electrical, implanted, for parkinsonian symptoms
MHY Stimulator, electrical, implanted, for parkinsonian tremor
SGS Deep Brain Stimulation for the treatment of Dystonia

GMDN Terms

Code Name
61393 Multiple active implantable device programmer

Identifiers

Type ID
Primary 00763000612832

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
P840001 512
P960009 438