FDA.reportPublic FDA data

Wearable Antenna Assembly

Primary DI
00818225020150
Brand
Wearable Antenna Assembly
Company
STIMWAVE TECHNOLOGIES INCORPORATED
Model
PDBT-915-2K
Device description
Wearable Antenna Assembly/StimQ Wearable Antenna Gear
Published
2018-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818225020150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818225020150008182250201508182250201500818225020150

GMDN Terms#

Term, Definition table
TermDefinition
Implantable spinal cord electrical stimulation system programmerA battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078294927
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818225021850PNS Wearable Accessory L/XL Vertical00-5200200-520022023-02-14
00818225021867PNS Wearable Accessory L/XL Horizontal00-520032023-02-14
00818225021874PNS Wearable Accessory S/M00-520042023-02-14
00818225022031Stimwave Freedom Spinal Cord Stimulation System00-520182023-02-14
00818225022048Stimwave Freedom Spinal Cord Stimulation System00-520132023-02-14
00818225022055Stimwave Freedom Spinal Cord Stimulation System00-520142023-02-14
00818225022062Stimwave Freedom Spinal Cord Stimulation System00-520152023-02-14
00818225022079Stimwave Freedom Spinal Cord Stimulation System00-520162023-02-14
00818225022086Stimwave Freedom Spinal Cord Stimulation System00-520172023-02-14
00818225020846StimQ SWAG Accessory Kit Upper ArmMD03472018-02-05
00818225020853StimQ SWAG Accessory Kit Lower ArmMD03462018-02-05
00818225020860StimQ SWAG Accessory Kit TorsoMD03452018-02-05
00818225020877StimQ SWAG Accessory Kit Upper LegMD03442018-02-05
00818225020884StimQ SWAG Accessory Kit Lower LegMD03392018-02-05
00850051034222SandShark Injectable Anchor SystemSHRK-ALL-1K-US2023-03-30
00818225020334"Small Antenna 12"" Length"MD0725-12-SS2018-10-25
00818225020525"Small Antenna 27"" Length"MD0725-27-SS2018-10-25
00818225020532"SeaSilk Antenna Large 28"" Length"MD0742-28-SS2018-10-25
00818225020549"SeaSilk Antenna Small 27"" Length"MD0812-27-SS2018-10-25
00818225020556"SeaSilk Antenna Small 12"" Length"MD0812-12-SS2018-10-25

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Primary DI, Brand, Company table
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00812537032986Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
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00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030203Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21