FDA.report

Neuro & Craniofacial Fixation System

Primary DI
M711LS4250
Brand
Neuro & Craniofacial Fixation System
Company
INNO Holdings, Inc.
Model
LS-425
Catalog number
LS-425
Device description
SST
Published
2018-08-13
Public version status
Update
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
HBGDrills, Burrs, Trephines & Accessories (Manual)

Product Code Classifications

CodeDeviceSpecialtyClass
HBGDrills, Burrs, Trephines & Accessories (Manual)Neurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
M711LS4250PrimaryHIBCC0

GMDN Terms

TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags

DUNS number
141620464
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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