FDA.reportPublic FDA data

NA

Primary DI
00845384017493
Brand
NA
Company
Synthes GmbH
Model
OCM
Catalog number
OCM
Device description
Otologic Curved Micro (OCM) Attachment
Published
2016-09-09
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
EQJBUR, EAR, NOSE AND THROAT
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131053000ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMThe Anspach Effort, Inc.2013-12-31ERL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384017493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384017493008453840174938453840174930845384017493

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
486711679
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
00821925033900DIEGOGyrus ACMI, LLCERL2024-07-25
00821925033917DIEGOGyrus ACMI, LLCERL2024-07-24
00821925034419DIEGOGyrus ACMI, LLCERL2024-07-23
07630055505026BASCH MicromotorBien-Air Surgery SAERL2023-02-10
07630055505040PMRM 1122 70mmBien-Air Surgery SAERL2023-02-09
07630055505095PMAM 1221 70 mmBien-Air Surgery SAERL2023-02-09
07613327501292iBurSTRYKER CORPORATIONERL2021-08-12
07613327501308iBurSTRYKER CORPORATIONERL2021-08-12
07613327504019NASTRYKER CORPORATIONERL2021-07-08
07630055502230Bur PM2-70 50K Diam Ø0.6Bien-Air Surgery SAEQJ2020-05-28
07630055502247Bur PM2-70 50K Diam Ø0.8Bien-Air Surgery SAEQJ2020-05-28
07630055502254Bur PM2-70 50K Diam Ø1.0Bien-Air Surgery SAEQJ2020-05-28
07630055502261Bur PM2-70 50K Diam Ø1.4Bien-Air Surgery SAEQJ2020-05-28
07630055502278Bur PM2-70 50K Diam Ø1.8Bien-Air Surgery SAEQJ2020-05-28
07630055502285Bur PM2-70 50K Diam Ø2.3Bien-Air Surgery SAEQJ2020-05-28
07630055502292Bur PM2-70 50K Diam Ø2.7Bien-Air Surgery SAEQJ2020-05-28
07630055502308Bur PM2-70 50K Diam Ø3.1Bien-Air Surgery SAEQJ2020-05-28
07630055502315Bur PM2-70 50K Diam Ø3.5Bien-Air Surgery SAEQJ2020-05-28
07630055502322Bur PM2-70 50K Diam Ø4.0Bien-Air Surgery SAEQJ2020-05-28
07630055502339Bur PM2-70 50K Diam Ø4.5Bien-Air Surgery SAEQJ2020-05-28
07630055502346Bur PM2-70 50K Diam Ø5.0Bien-Air Surgery SAEQJ2020-05-28
07630055502353Bur PM2-70 50K Diam Ø6.0Bien-Air Surgery SAEQJ2020-05-28
07630055502360Bur PM2-70 50K Diam Ø7.0Bien-Air Surgery SAEQJ2020-05-28
07630055502377Bur PM2-70 50K Carb Ø0.5Bien-Air Surgery SAEQJ2020-05-28