TD2 Limb Cuff

GUDID 00812537037141

The limb cuff holds the Therapy Disc in place over the Implantable Pulse Generator location.

NALU MEDICAL, INC.

Personal device holder, reusable
Primary Device ID00812537037141
NIH Device Record Keyf33cee47-bcf5-4876-a195-403ec12d7971
Commercial Distribution StatusIn Commercial Distribution
Brand NameTD2 Limb Cuff
Version Model Number34019
Company DUNS067140761
Company NameNALU MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812537037141 [Primary]

FDA Product Code

GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-05
Device Publish Date2026-02-25

Devices Manufactured by NALU MEDICAL, INC.

00812537037431 - 25cm Straight Stylet2026-03-06 Stiff wire(s) with a straight tip that is inserted into the Lead to aid in steering and positioning.
00812537037448 - 40cm Straight Stylet2026-03-06 Stiff wire(s) with a straight tip that is inserted into the Lead to aid in steering and positioning.
00812537037462 - Extended Torque Wrench2026-03-06 A torque limited hex driver that is used to tighten the connector set screws and the Anchor.
00812537037691 - Lead Kit (4 Contact, 25cm, Tined)2026-03-06 The stimulating portion of the neurostimulator that is inserted subcutaneously near the target nerve. The kit includes the Tined
00812537037707 - Lead Kit (4-Contact, 40cm, Tined)2026-03-06 The stimulating portion of the neurostimulator that is inserted subcutaneously near the target nerve. The kit includes one (1) T
00812537037141 - TD2 Limb Cuff2026-03-05The limb cuff holds the Therapy Disc in place over the Implantable Pulse Generator location.
00812537037141 - TD2 Limb Cuff2026-03-05 The limb cuff holds the Therapy Disc in place over the Implantable Pulse Generator location.
00812537037158 - TD2 Thigh Wrap2026-03-05 The thigh wrap is an alternative to the adhesive clip for holding the therapy disc in place on the body. The Therapy Disc is ins
00812537037165 - TD2 Relief Belt, Large2026-03-05 The relief belt is an alternative to the adhesive clip for holding the therapy disc in place on the body. The Therapy Disc is in

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