FDA.report

LEOS Cannulated Screw System

Primary DI
00810040689307
Brand
LEOS Cannulated Screw System
Company
Tyber Medical LLC
Model
76308522
Catalog number
76308522
Device description
Countersink 2.0 Cann HLESS Screws
Published
2023-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWWCOUNTERSINK

Product Code Classifications

CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810040689307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040689307008100406893078100406893070810040689307

GMDN Terms

TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)761-0933preese@tybermed.com

Regulatory Flags

DUNS number
010968002
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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