FDA.reportPublic FDA data

NA

Primary DI
00845384001782
Brand
NA
Company
Synthes GmbH
Model
CSR60
Catalog number
CSR60
Device description
Perforator Driver with Hudson End, 60:1 Ratio. Use with XMax, eMax Systems.
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
HBBMOTOR, DRILL, PNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960630000ANSPAHC SPEED REDUCERThe Anspach Effort, Inc.1996-11-19HBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384001782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384001782008453840017828453840017820845384001782

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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251388960530VELOCITY ALPHA ™adeor Medical AGHBB2026-03-31
04251388910801VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388924105VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959954VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959961VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388959978VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388960448VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
04251388961001VELOCITY ALPHA ™adeor Medical AGHBB2026-03-30
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2026-03-09
00763000521622MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-08-10
20763000722313ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722337ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722326ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722340ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
20763000722399MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
20763000722429MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722401MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000722418MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-21
00763000988784Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000988791Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
00763000651169Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-22
00763000521813MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-20
00763000714499MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714505MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000714604MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-01-16
00763000930837MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-10-03
00763000714482MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714536MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-08-19
00763000714550MR8 ToolsMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-04-27
00763000732943MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2024-01-18