FDA.reportPublic FDA data

Turbett Surgical, Inc.

Primary DI
10859464007301
Brand
Turbett Surgical, Inc.
Company
Turbett Surgical Inc
Model
TS1834KIT
Device description
TS1200 Filter Kit, 10 pack
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859464007301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085946400730110859464007301

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5857550133customerservice@turbettsurgical.com

Regulatory Flags#

DUNS number
080273036
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859464007540Turbett Surgical, Inc. TS15302025-12-11
00859464007557Turbett Surgical, Inc. TS15352025-12-11
00859464007564Turbett Surgical, Inc. TS15652025-12-11
00859464007571Turbett Surgical, Inc. TS12602025-12-11
00859464007588Turbett Surgical, Inc. TS10652025-12-11
00859464007595Turbett Surgical, Inc. TS15712025-12-11
00859464007601Turbett Surgical, Inc. TS12712025-12-11
00859464007618Turbett Surgical, Inc. TS10712025-12-11
00859464007625Turbett Surgical, Inc. TS20602025-12-11
00859464007649Turbett Surgical, Inc. TS3010P2025-12-11
00859464007656Turbett Surgical, Inc. TS3070P2025-12-11
00859464007663Turbett Surgical, Inc. TS3080P2025-12-11
00859464007670Turbett Surgical, Inc. TS80102025-12-11
00859464007687Turbett Surgical, Inc. TS80122025-12-11
00859464007694Turbett Surgical, Inc. TS80152025-12-11
10859464007134Turbett Surgical, Inc. TS2434KITTS2434KIT2025-12-11
10859464007226Turbett Surgical, Inc. TS1824KIT2025-12-11
00859464007052Turbett SurgicalTS30102024-04-25
00859464007069Turbett SurgicalTS30202024-04-25
00859464007076Turbett SurgicalTS30352024-04-25

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Primary DI, Brand, Company table
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