FDA.reportPublic FDA data

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845384018759EG1™WIRELESS-HCWIRELESS-HC2022-07-08
00845384018766EG1™RECEIVER-HCRECEIVER-HC2022-07-08
00845384014249NAL-5B-A-G1L-5B-A-G12016-09-09
00845384012269NAHK-2100-02-FPHK-2100-02-FP2016-10-17
00845384012290NAAL-9152-00-FPAL-9152-00-FP2016-10-17
00845384002536NAHOSE-20-DISSHOSE-20-DISS2016-10-17
00845384005599NAMUFFLER-ASSYMUFFLER-ASSY2016-10-17
00845384010784NAXM-CASEXM-CASE2018-02-05
00845384010791NAXMAXXMAX2018-02-05
00845384012276NA16-3100-FP16-3100-FP2016-09-09
00845384012313NAHE-4005-10-FPHE-4005-10-FP2016-09-09
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBE2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBE2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAHBE2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAHBE2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBE2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBE2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAHBE2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SAHBE2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAHBE2023-02-10
07630055505866Cranio Guard 10mm fixBien-Air Surgery SAHBE2023-02-10
07630055505873Cranio Guard 15mm fixBien-Air Surgery SAHBE2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAHBE2023-02-10
07630055505927PM2-S150Bien-Air Surgery SAHBE2023-02-10
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09
07630055505699PM2-S70Bien-Air Surgery SAHBE2023-02-09
07630055505705PM2-A95Bien-Air Surgery SAHBE2023-02-09
07630055505712PM2-A125Bien-Air Surgery SAHBE2023-02-09
07630055505729NANO MicromotorBien-Air Surgery SAHBE2023-02-09
07630055505750PM2-A70HDBien-Air Surgery SAHBE2023-02-09
07630055505767PM2-S70HDBien-Air Surgery SAHBE2023-02-09