NA

Primary DI
00845384002673
Brand
NA
Company
Anspach Effort, The
Model
IMRI-SHORT
Catalog number
IMRI-SHORT
Device description
5 cm Short Attachment. Use with iMRI System Only
Published
2018-02-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBBMOTOR, DRILL, PNEUMATIC
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040186000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040186000ANSPACH MRI SAFE SURGICAL DRILL SYSTEMThe Anspach Effort, Inc.2004-04-15HBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384002673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384002673008453840026738453840026730845384002673

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA 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 burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head 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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500RA-DPYNA-anspachpowe@its.jnj.com

Regulatory Flags#

DUNS number
079116867
Device count
1
Serial number
true
Sterilization required before use
true

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00845384005599NAMUFFLER-ASSYMUFFLER-ASSY2016-10-17
00845384010784NAXM-CASEXM-CASE2018-02-05
00845384010791NAXMAXXMAX2018-02-05
00845384012276NA16-3100-FP16-3100-FP2016-09-09
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00845384012320NA45-0432-FP45-0432-FP2016-09-09
00845384016595NAE-HCE-HC2018-02-05
00845384006343NAQD11-8NDQD11-8ND2016-09-09
00845384016588NAMIA16-5DRMMIA16-5DRM2016-09-09
00845384000396NAAUTOLUBE-IIIAUTOLUBE-III2016-10-17
00845384000402NAAUTOLUBE-III-20AUTOLUBE-III-202016-10-17
00845384000457NAAUTOLUBE-III-IRRAUTOLUBE-III-IRR2016-10-17
00845384000464NAAUTOLUBE-III-MA7AUTOLUBE-III-MA72016-10-17
00845384001676NACDACDA2018-02-05

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Primary DI, Brand, Company table
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04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
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