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
10887587078540NASD03.501.442SD035014422026-07-29
10886982362179NASD03.043.006SD030430062026-07-24
10887587078557NASD03.503.067SD035030672026-07-24
10887587078564NASD03.503.072SD035030722026-07-24
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08

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
07630055505132PMAM 1122 95mmBien-Air Surgery SAERL2023-02-09
07630055505149PMAM 1122 125mmBien-Air Surgery SAERL2023-02-09
07630055505156PMAM 1221 95mmBien-Air Surgery SAERL2023-02-09
07630055505163PMAM 1221 125mmBien-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