AccessGUDID - DEVICE: SeaSilk Antenna Large 28" Length (00818225020532)

GUDID

Device Identifier (DI) Information

Brand Name: SeaSilk Antenna Large 28" Length
Version or Model: MD0742-28-SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STIMWAVE TECHNOLOGIES INCORPORATED

Primary DI Number: 00818225020532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078294927 *Terms of Use

Device Description: SeaSilk Antenna Large 28" Length

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61393	Multiple active implantable device programmer	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180981	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -29 and 60 Degrees Celsius
Storage Environment Temperature: between -20 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 71.12 Centimeter
Length: 28 Inch

Device Record Status

Public Device Record Key: 6a629ed4-a9ac-4738-80e7-e60244d383ca
Public Version Date: July 07, 2020
Public Version Number: 2
DI Record Publish Date: October 25, 2018