13G Tuohy Needle 6"

GUDID 00859619004646

13G Tuohy Needle 6"

STIMWAVE TECHNOLOGIES INCORPORATED

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID00859619004646
NIH Device Record Key5620bac0-022d-4d8c-9b26-77db3f0dc1a6
Commercial Distribution StatusIn Commercial Distribution
Brand Name13G Tuohy Needle 6"
Version Model NumberMD0532-A
Company DUNS078294927
Company NameSTIMWAVE TECHNOLOGIES INCORPORATED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length6 Inch
Length6 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -20 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100859619004646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBStimulator, Spinal-Cord, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00859619004646]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-26
Device Publish Date2018-10-25

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