FDA.reportPublic FDA data

SureLock®

Primary DI
M543CM9623
Brand
SureLock®
Company
CAYENNE MEDICAL, INC.
Model
CM-9623
Catalog number
CM-9623
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NBHAccessories, Arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M543CM9623PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606719685
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M543CM8010Quattro®CM-8010CM-80102019-03-29
M543CM6127BioWick SureLockCM-61272016-01-10
M543CM6255BioWick XCM-62552018-01-31
M543CM6265BioWick XCM-62652018-01-25
00887868269769BioWick® SureLock®CM-61272020-09-21
00887868269790BioWick® XCM-62552020-09-21
00887868269813BioWick® XCM-62652020-09-21
M5431100259901Ventix™1100259901100259902018-12-04
M5431100259921Ventix™1100259921100259922018-12-04
M543CM1025iFix®CM-10252015-10-09
M543CM1030iFix®CM-10302015-10-09
M543CM1130iFix®CM-11302015-10-09
M543CM1230iFix®CM-12302015-10-09
M543CM1720iFix®CM-17202015-10-09
M543CM1725iFix®CM-17252015-10-09
M543CM1820iFix®CM-18202015-10-09
M543CM1825iFix®CM-18252015-10-09
M543CM1830iFix®CM-18302015-10-09
M543CM1920iFix®CM-19202015-10-09
M543CM1925iFix®CM-19252015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093258ELMED INCORPORATEDELMED INCORPORATEDNBH2026-07-28
00810143908534SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909449SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909456SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909463SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909470SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909487SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909494SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909500SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909531SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909555SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909562SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909579SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909623SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909630SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909647SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909654SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909661SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909678SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909685SURGIPROSSurgipros, LLCNBH2026-07-28
00810143909791SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934334SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934341SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934358SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934365SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934372SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934389SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934396SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934402SURGIPROSSurgipros, LLCNBH2026-07-28
00810212934419SURGIPROSSurgipros, LLCNBH2026-07-28