FDA.reportPublic FDA data

Quattro®

Primary DI
M543CM8010
Brand
Quattro®
Company
CAYENNE MEDICAL, INC.
Model
CM-8010
Catalog number
CM-8010
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
M543CM8010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Infant whole-body immobilizer, single-useA non-sterile, non-rigid device, usually made of a fabric and/or plastic materials, intended to be used to temporarily render an infant's whole body immovable (strait-jacket effect) while the patient undergoes therapeutic (e.g., phototherapy) or diagnostic interventions. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
606719685
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
M543CM1930iFix®CM-19302015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867568280Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568297Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568303Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568310Arthrex®ARTHREX, INC.NBH2026-10-16
00888867568457Arthrex®ARTHREX, INC.NBH2026-10-16
B382SD4830070Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD4840320Surgical DirectSurgical Direct, Inc.NBH2026-10-15
B382SD18146S90Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316490Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316690Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD316890Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4810320Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482014PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD482036PH0Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD4843590Surgical DirectSurgical Direct, Inc.NBH2026-10-13
B382SD488200810Surgical DirectSurgical Direct, Inc.NBH2026-10-13
00888867620964Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620971Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620988Arthrex®ARTHREX, INC.NBH2026-10-12
00888867620995Arthrex®ARTHREX, INC.NBH2026-10-12
00190776434021MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776434106MillenniumAvalign Technologies, Inc.NBH2026-10-09
00190776433680MillenniumAvalign Technologies, Inc.NBH2026-10-07
00190776433123MillenniumAvalign Technologies, Inc.NBH2026-10-01
04055207071786NARichard Wolf GmbHNBH2026-10-01
04055207071830NARichard Wolf GmbHNBH2026-10-01
00190776431495MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776432119MillenniumAvalign Technologies, Inc.NBH2026-09-22
00190776431136MillenniumAvalign Technologies, Inc.NBH2026-09-21
00190776431143MillenniumAvalign Technologies, Inc.NBH2026-09-21