FDA.reportPublic FDA data

Bl Pointer Straight-Extended

Primary DI
04056481002152
Brand
Bl Pointer Straight-Extended
Company
Brainlab SE
Model
52781A
Catalog number
52781A
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481002152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481002152040564810021524056481002152

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It typically consists of an operator's console featuring a robotic surgical arm(s) and a video camera used to track the robotic instrumentation. The input to the computer is usually by means of an existing CT or MRI scan. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
314482980
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres M581932026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres ML581942026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres L581952026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1581962026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2581972026-10-29
04056481147693Quip Instrument Adapter Clamp Size S582102026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size M582112026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size L582122026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XL582132026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular Instruments582142026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical Instruments582152026-10-29
04056481147754Quip Instrument Adapter Extension 50 mm582162026-10-29
04056481147761Quip Instrument Adapter 45° Angled582172026-10-29
04056481145323Patient Reference Carbon-Clamp Spine & Trauma558232026-10-27
04056481148201Sterilization Tray Accessories Spine52306C2026-10-27
04056481148218Sterilization Tray Accessories Spine & Trauma52326A2026-10-27
04056481148225Sterilization Tray Accessories Spine MIS52313B2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMF52311A2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)52305A2026-10-27
04056481146207Spine Planning3.02026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088866018CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866025CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866032CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866049CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866056CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866063CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866070CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866087CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866094CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866100CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866117CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866124CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866131CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866148CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866155CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866162CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866179CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866186CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866193CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866209CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866216CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866223CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866230CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866247CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866254CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866261CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866278CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866285CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866292CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866308CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29