FDA.reportPublic FDA data

Cannulated Screw System +

Primary DI
00810040683602
Brand
Cannulated Screw System +
Company
Tyber Medical, LLC
Model
60.333.200
Catalog number
60.333.200
Device description
OUTER CASE 1/3 LENGTH 3 HIGH WITH LID
Published
2020-05-21
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
LXHOrthopedic manual surgical instrument
PXVGeneral purpose instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
PXVGeneral Purpose Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040683602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040683602008100406836028100406836020810040683602

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. 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
00196449017645Anatomic Access LLIF818000362026-06-23
00196449035373Anatomic Access LLIF818000132026-06-23
00196449010134Anatomic Access LLIF818000292026-06-09
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00196449035298Anatomic Access LLIF818000052026-06-09
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00196449035328Anatomic Access LLIF818000082026-06-09
00196449035335Anatomic Access LLIF818000092026-06-09
00196449035366Anatomic Access LLIF818000122026-06-09
00196449035380Anatomic Access LLIF818000142026-06-09
00196449035397Anatomic Access LLIF818000152026-06-09
00196449035441Anatomic Access LLIF818000202026-06-09
00196449035465Anatomic Access LLIF818000222026-06-09
00196449035472Anatomic Access LLIF818000232026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
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00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
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00889929072448Matrixx SystemNEXXT SPINE, LLCLXH2026-07-17