FDA.reportPublic FDA data

TSI

Primary DI
00851797006795
Brand
TSI
Company
TEDAN SURGICAL INNOVATIONS, L.L.C.
Model
TK-1245
Device description
CONCAVE SPATULA, 75 MM, 13 MM, SST
Published
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZTRetractor, Self-Retaining, For Neurosurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZTRetractor, Self-Retaining, For NeurosurgeryNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161318000Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding SystemsTedan Surgical Innovations, LLC2017-03-20GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851797006795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851797006795008517970067958517970067950851797006795

GMDN Terms#

Term, Definition table
TermDefinition
Brain spatulaA hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat blunt blade (no sharp edges) that can be slightly curved or have various angles at the distal tip, or it can be double-ended. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
791619393
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843059126945MedtronicMDT-0442S2026-04-28
00843059126969MedtronicMDT-0459S2026-04-28
00843059126990MedtronicMDT-0469S2026-04-28
008430591217353CorD-00122018-08-09
008430591217593CorD-00162018-08-09
00843059121797LDR Spine USA0022LDR2018-08-09
00843059121803LDR Spine USA0024LDR2018-08-09
00843059125979TSIUL-0360SUL-0360S-052022-07-15
00843059125986TSIUL-0362SUL-0362S-052022-07-15
00843059125993TSIUL-0364SUL-0364S-052022-07-15
00843059126006TSIUL-0366SUL-0366S-052022-07-15
00843059126013TSIUL-0368SUL-0368S-052022-07-15
00843059126020TSIUL-0370SUL-0370S-052022-07-15
00843059126037TSIUL-0372SUL-0372S-052022-07-15
00843059126044TSIUL-0374SUL-0374S-052022-07-15
00843059126051TSIUL-0376SUL-0376S-052022-07-15
00843059126068TSIUL-0378SUL-0378S-052022-07-15
00851797006443TSIDS-00122017-05-22
00851797006450TSIDS-00142017-05-22
00851797006467TSIDS-00162017-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780537533Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537571Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537588Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537625TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537649TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537663TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537670TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537694TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537717TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537724TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537748TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537779Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537816TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537854TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537861TEW?INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537878Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537885Budde®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537908MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537915MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537960MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780537977MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538004MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
10381780538042BUDDE®INTEGRA LIFESCIENCES CORPORATIONGZT2024-06-28
00816744028459NICO BrainPathNICO CORPORATIONGZT2020-04-15
10381780344605Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344612Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344629Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344636Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344643Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23
10381780344650Integra®INTEGRA LIFESCIENCES CORPORATIONGZT2019-01-23