Model: TH91SCSR
DI: 00199150044405
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
COMM HANDSET KIT TH91SCSR PAIN US A13
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
36f00a5a-07c1-4a53-b299-4d7a0e7ed251
Distribution Status:
In Commercial Distribution
DUNS Number:
006261481
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00199150044405
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61393
Name: Multiple active implantable device programmer
Definition:
An 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.
FDA Product Codes
QRB
Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
LGW
Stimulator, spinal-cord, totally implanted for pain relief
Premarket Submissions
Submission Number:
P840001
Supplement Number:
512