FDA.reportPublic FDA data

Spetzler - OMT

Primary DI
M731100020
Brand
Spetzler - OMT
Company
OMT, LLC
Model
Neuro Patties
Catalog number
ALL
Device description
Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
Published
2017-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBANeurosurgical Paddie

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBANeurosurgical PaddieNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020736000TRAATEK COTTONOID PATTIESTraatek, Inc.2002-06-03HBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7311100109PackageHIBCC20In Commercial Distribution
M7311100119PackageHIBCC10In Commercial Distribution
M7311100129PackageHIBCC8In Commercial Distribution
M7311100139PackageHIBCC4In Commercial Distribution
M7311100149PackageHIBCC3In Commercial Distribution
M7311100179PackageHIBCC10In Commercial Distribution
M7311100199PackageHIBCC5In Commercial Distribution
M731110199PackageHIBCC5In Commercial Distribution
M731100020PrimaryHIBCC0
K900010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cottonoid padA cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature30 Degrees Fahrenheit70 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
954-327-5687regulatory@omtmedical.com

Regulatory Flags#

DUNS number
196899772
Device count
10
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
M731K90019Spetzler Neuro PattiesK SeriesK-90012025-12-31
M731K90049Spetzler Neuro PattiesK SeriesK-90042025-12-31
M731K90059Spetzler Neuro PattiesK SeriesK-90052025-12-31
M731K90069Spetzler Neuro PattiesK SeriesK-90062025-12-31
M731K90079Spetzler Neuro PattiesK SeriesK-90072025-12-31
M731K90089Spetzler Neuro PattiesK SeriesK-90082025-12-31
M731K90099Spetzler Neuro PattiesK SeriesK-90092025-12-31
M731K90109Spetzler Neuro PattiesK SeriesK-90102025-12-31
M731K90159Spetzler Neuro PattiesK SeriesK-90152025-12-31
M731K90169Spetzler Neuro PattiesK SeriesK-90162025-12-31
M731K90179Spetzler Neuro PattiesK SeriesK-90172025-12-31
M731K90189Spetzler Neuro PattiesK SeriesK-90182025-12-31
M731K90199Spetzler Neuro PattiesK SeriesK-90192025-12-31
M731K90209Spetzler Neuro PattiesK SeriesK-90202025-12-31
M731K90219Spetzler Neuro PattiesK SeriesK-90212025-12-31
M731K90229Spetzler Neuro PattiesK SeriesK-90222025-12-31
M731K90239Spetzler Neuro PattiesK SeriesK-90232025-12-31
M731K90269Spetzler Neuro PattiesK SeriesK-90262025-12-31
M731K90279Spetzler Neuro PattiesK SeriesK-90272025-12-31
M731K90289Spetzler Neuro PattiesK SeriesK-90282025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000663292ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663308ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663346ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663353ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663735ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
M731K90019Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90049Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90059Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90069Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90079Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90089Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90099Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90109Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90159Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90169Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90179Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90189Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90199Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90209Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90219Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90229Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90239Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90269Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90279Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90289Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90299Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90509Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90519Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90529Spetzler Neuro PattiesOMT, LLCHBA2025-12-31