FDA.reportPublic FDA data

Drill Depth Stop Cranial 4.9 mm

Primary DI
04056481145927
Brand
Drill Depth Stop Cranial 4.9 mm
Company
Brainlab SE
Model
56406-49
Published
2025-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243698000Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITTBrainlab AG2025-01-28HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481145927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481145927040564811459274056481145927

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant depth limiter, reusableA device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314482980
Device count
1
Lot or batch
true
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
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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
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