FDA.reportPublic FDA data

Drill Guide Kit (0.085'')

Primary DI
04056481006402
Brand
Drill Guide Kit (0.085'')
Company
Brainlab SE
Model
19779
Catalog number
19779
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
HCACatheter, Ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HCACatheter, VentricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123605000
K132436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123605000SMARTFLOW CATHETERMri Interventions, Inc.2013-08-16HCA
K132436000VARIOGUIDE DRILL KITMri Interventions, Inc.2014-03-20HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481006402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481006402040564810064024056481006402

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-use, sterileA sterile, hand-held, tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49899915680contact@brainlab.com

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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