FDA.reportPublic FDA data

Turbett Surgical

Primary DI
00859464007366
Brand
Turbett Surgical
Company
Turbett Surgical Inc
Model
TS2011
Device description
Sterile Loading Assembly Reversable
Published
2024-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00859464007366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859464007366008594640073668594640073660859464007366

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
DM exempt
true
Lot or batch
true
Serial number
true

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
10859464007301Turbett Surgical, Inc. TS1834KIT2025-12-11
00859464007052Turbett SurgicalTS30102024-04-25
00859464007069Turbett SurgicalTS30202024-04-25

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Primary DI, Brand, Company table
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