FDA.reportPublic FDA data

NA

Primary DI
04546540130488
Brand
NA
Company
STRYKER CORPORATION
Model
0864011000
Catalog number
0864011000
Device description
Disposable Bag
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGHINSTRUMENT, CAST REMOVAL, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGHInstrument, Cast Removal, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540130489PackageGS112In Commercial Distribution
04546540130488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654013048934546540130489
04546540130488045465401304884546540130488

GMDN Terms#

Term, Definition table
TermDefinition
Cast cutter vacuum systemAn assembly of devices designed to collect the dust produced by a cast cutter (e.g., pneumatic or electric cast saw) from the workspace environment by suction during the cast removal procedure. It typically consists of a motorized vacuum pump, a filter, and a collection container (e.g., bag or cartridge). It is typically a portable unit and its motor may run concurrently with the saw motor.

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210Inst.Stryker.cs@Stryker.com

Regulatory Flags#

DUNS number
196548481
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850024195028MOLLIMM10002021-08-27
00850024195134MOLLIMS-00009MM10122022-06-27
00850024195219MOLLIMP2015A2024-04-13
00850024195141MOLLIMP20012023-03-30
00850024195158MOLLIMT20012023-03-30
00850024195004MOLLIMP10012021-08-27
00850024195011MOLLIMT10012021-08-27
07613327651232SportSuite0203-10000203-10002026-08-21
07613327679410Mini-PRO Pediatric Restraint System (with Modified X-Restraints)6410055500016410055500012026-08-21
07613327170559VertaPlex HV04066220150406-622-0152016-09-23
07613327358308iVAS8080108000808-010-8002019-01-11
04546540434371PCD SpinePlex05055820000505-582-0002015-09-24
04546540434388PCD SpinePlex05055830000505-583-0002015-09-24
04546540434395PCD SpinePlex05055850000505-585-0002015-09-24
04546540434401PCD SpinePlex05055860000505-586-0002015-09-24
04546540434418PCD05055870000505-587-0002015-09-24
04546540434425PCD05055890000505-589-0002015-09-24
07613327639032Broadway SystemBRW8E100D-3PK01BRW8E100D-3PK012025-03-12
07613327639049Broadway SystemBRW8E105D-3PK01BRW8E105D-3PK012025-03-12
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471208803De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-06-17
05060528013192De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013208De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013215De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013222De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
04042809703535Delta-Cast SereneBSN MEDICAL, INC.LGH2025-03-07
04042809721966Delta-Cast SereneBSN MEDICAL, INC.LGH2025-03-07
05051471208773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471208780De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471208797De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471000513De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471000766De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471000773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471001398De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471001824De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471005198De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471005204De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006355De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006362De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006379De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006386De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006409De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006959De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471009646De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471011458De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471011465De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471012332De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471015364De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471015432De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471016163De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25