FDA.reportPublic FDA data

Thompson

Primary DI
00841536118575
Brand
Thompson
Company
Thompson Surgical Instruments, Inc.
Model
47111
Device description
Brain Retractor 9x102mm
Published
2022-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K210615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210615000Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.2022-05-13GZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841536118575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841536118575008415361185758415361185750841536118575

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical retraction system, brainA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism dedicated to the temporary parting of brain tissue during neurosurgery. It includes a mounting frame, mountable retracting blades, and may be intended to attach to a skull clamp (not included). It is typically made of high-grade stainless steel and synthetic polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2316425603ken.gmoser@thompsonsurgical.com

Regulatory Flags#

DUNS number
081334746
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
00841536101812ThompsonSL45619AT2022-08-11
00841536101379ThompsonSL45602AT2020-08-07
00841536101386ThompsonSL45603AT2020-08-07
00841536101393ThompsonSL45610AT2020-08-07
00841536101799ThompsonSL45611AT2020-08-07
00841536101805ThompsonSL45618AT2020-08-07
00841536120165ThompsonS45601Q2020-08-07
00841536120189ThompsonS45616Q2020-08-07
00841536121100ThompsonSL45600AT2020-08-07
00841536121124ThompsonSL45601AT2020-08-07
00841536121230ThompsonSL45614AT2020-08-07
00841536125511ThompsonSO45612AETT2020-08-09
00841536125528ThompsonSO45612AT2020-08-09
00841536125542ThompsonSO45613AT2020-08-09
00841536125566ThompsonSO45615AT2020-08-09
00841536125580ThompsonSO45616AT2020-08-09
00841536112610Thompson45600AT2020-08-04
00841536112634Thompson45601AT2020-08-04
00841536112658Thompson45602AT2020-08-04
00841536112672Thompson45603AT2020-08-04

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