FDA.reportPublic FDA data

LEOS Cannulated Screw System

Primary DI
00810040689321
Brand
LEOS Cannulated Screw System
Company
Tyber Medical, LLC
Model
76308524
Catalog number
76308524
Device description
Cleaning Stylet 2.0 Screws
Published
2023-12-08
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040689321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040689321008100406893218100406893210810040689321

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
010968002
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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

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