FDA.reportPublic FDA data

"SeaSilk Antenna Large 28"" Length"

Primary DI
00818225020532
Brand
"SeaSilk Antenna Large 28"" Length"
Company
STIMWAVE TECHNOLOGIES INCORPORATED
Model
MD0742-28-SS
Device description
"SeaSilk Antenna Large 28"" Length"
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)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180981000Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated2018-09-19GZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818225020532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818225020532008182250205328182250205320818225020532

GMDN Terms#

Term, Definition table
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 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Inch
Length71.12Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-20 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
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
00818225020150Wearable Antenna AssemblyPDBT-915-2K2018-10-25
00818225020334"Small Antenna 12"" Length"MD0725-12-SS2018-10-25
00818225020525"Small Antenna 27"" Length"MD0725-27-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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