FDA.reportPublic FDA data

SeaSpine

Primary DI
00851797006429
Brand
SeaSpine
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
ML-0459
Device description
Disposable Dilator KitKit Contains:ML-0444SInsulated Dilator Set, 7, 12, & 15 MM, SterileML-0445Stimulation Clip, 5-22mm, Single Use, 1/Each, Sterile
Published
2017-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IKDCable, Electrode
PDQNeurosurgical Nerve Locator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2
PDQNeurosurgical Nerve LocatorEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851797006429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851797006429008517970064298517970064290851797006429

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating system, line-poweredAn assembly of mains electricity (AC-powered) devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system typically includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width7Millimeter
Width12Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791619393
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843059127188LattusLAT-20062026-07-20
00843059127195LattusLAT-20072026-07-20
00843059127201LattusLAT-21202026-07-20
00843059127218LattusLAT-31202026-07-20
00843059127225LattusLAT-40902026-07-20
00843059127232LattusLAT-41002026-07-20
00843059127249LattusLAT-41102026-07-20
00843059127256LattusLAT-41202026-07-20
00843059127263LattusLAT-41302026-07-20
00843059127270LattusLAT-41402026-07-20
00843059127287LattusLAT-41502026-07-20
00843059127294LattusLAT-41602026-07-20
00843059127300LattusLAT-41702026-07-20
00843059127317LattusLAT-41802026-07-20
00843059127331LattusLAT-15632026-07-20
00843059127348LattusLAT-15312026-07-20
00843059127355LattusLAT-15322026-07-20
00843059127379LattusLAT-15042026-07-20
00843059127386LattusLAT-05142026-07-20
00843059127393LattusLAT-15152026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572283APKAPK Technology Co.,Ltd.IKD2026-09-04
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14