FDA.reportPublic FDA data

Headless Screw System Instruments

Primary DI
00810030824992
Brand
Headless Screw System Instruments
Company
Tyber Medical, LLC
Model
T001000093
Catalog number
T001000093
Device description
Ø5.0 Screw Caddy
Published
2020-01-14
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
PXVGeneral purpose instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXVGeneral Purpose Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810030824992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810030824992008100308249928100308249920810030824992

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933jstigliano@tybermed.com

Regulatory Flags#

DUNS number
010968002
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810040684050Cannulated Compression Headless Screw03.333.31203.333.3122020-08-20
00196449021161VOLT™ Wrist Treatment System02.426.6452026-04-10
00196449021178VOLT™ Wrist Treatment System04.426.6452026-04-10
00196449021185VOLT™ Wrist Treatment System02.426.6462026-04-10
00196449021192VOLT™ Wrist Treatment System02.426.6472026-04-10
00196449021208VOLT™ Wrist Treatment System04.426.6462026-04-10
00196449021215VOLT™ Wrist Treatment System04.426.6472026-04-10
00196449021222VOLT™ Wrist Treatment System02.426.2502026-04-10
00196449021239VOLT™ Wrist Treatment System02.426.2552026-04-10
00196449021246VOLT™ Wrist Treatment System02.426.2602026-04-10
00196449021253VOLT™ Wrist Treatment System04.426.2502026-04-10
00196449021260VOLT™ Wrist Treatment System04.426.2552026-04-10
00196449021277VOLT™ Wrist Treatment System04.426.2602026-04-10
00196449021888VOLT™ Wrist Treatment System02.426.7332026-04-10
00196449021895VOLT™ Wrist Treatment System02.426.7322026-04-10
00196449021901VOLT™ Wrist Treatment System04.426.7332026-04-10
00196449021918VOLT™ Wrist Treatment System04.426.7322026-04-10
00196449021925VOLT™ Wrist Treatment System02.426.9112026-04-10
00196449021932VOLT™ Wrist Treatment System02.426.9102026-04-10
00196449021949VOLT™ Wrist Treatment System02.426.9212026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956281660CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
50198956281668CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
10198956244580CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
50198956244588CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
10198956251915CARDINAL HEALTHCardinal Health 200, LLCPXV2025-11-04
10198956210370CARDINAL HEALTHCardinal Health 200, LLCPXV2025-10-03
10198956137479CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956137477CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
10198956057500CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
50198956057508CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
00843356102741CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102758CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102765CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102772CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102789CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102796CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102744CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102751CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102768CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102775CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102782CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102799CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
10197106773284CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
50197106773282CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
00843356102819CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102826CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102833CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032440MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032457MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08