FDA.reportPublic FDA data

NA

Primary DI
00845384016595
Brand
NA
Company
Anspach Effort, The
Model
E-HC
Catalog number
E-HC
Device description
Hand Control, Electric Handpiece EM
Published
2018-02-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBCMOTOR, DRILL, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBCMotor, Drill, ElectricNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011444000ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc.2001-08-08HBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384016595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384016595008453840165958453840165950845384016595

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical power tool system, line-poweredAn assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).

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
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
00845384001683NACDA-1RCDA-1R2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260473430TRAUSSaeshin Precision Co., Ltd.HBC2026-05-20
08809260475489TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475496TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475502TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475427TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475434TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475441TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475465TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475472TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHERL2025-12-18
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHERL2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHERL2025-07-08
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBC2025-03-21
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAERL2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAERL2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBC2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAERL2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAERL2025-03-20
J021304680001S-10 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021304700001S-12 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2024-02-07
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHERL2023-10-12
J021303930011M-MH40 RIWOSpineW & H Dentalwerk Bürmoos GmbHERL2023-10-12
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAERL2023-02-22