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
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

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