FDA.reportPublic FDA data

NA

Primary DI
04546540898562
Brand
NA
Company
STRYKER CORPORATION
Model
0300040000
Catalog number
0300-040-000
Device description
Bucket Liners
Published
2018-09-24
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
LGGINSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540898563PackageGS1100Not in Commercial Distribution
04546540898562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654089856334546540898563
04546540898562045465408985624546540898562

GMDN Terms#

Term, Definition table
TermDefinition
Bucket linerA device used to line a bucket in order to create a barrier to contamination and serve as the basis for preventing cross-contamination, reducing cleaning requirements, and protecting the bucket surface finish. This liner will typically be used in swab buckets, commonly known as kick buckets. This is a single-use device.

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
00190776407308MillenniumAvalign Technologies, Inc.LGG2026-07-28
00190776421526MillenniumAvalign Technologies, Inc.LGG2026-05-05
00810058670533Professional Surgical Instruments Co., Inc. Professional Surgical Instruments Co., Inc.LGG2026-02-12
00194613087906MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-08-01
04049047005001GimmiGimmi GmbHLGG2025-04-02
00194613008345MSI Precision Specialty InstrumentsMed Saver, Inc.LGG2025-03-21
00840306823039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LGG2025-01-17
00887482044421Symmetry Wolff-BoehlerASPEN SURGICAL PRODUCTS, INC.LGG2024-08-15
00887482054772Symmetry Wolfe-BoehlerASPEN SURGICAL PRODUCTS, INC.LGG2024-08-15
00887482037287Symmetry WaltonASPEN SURGICAL PRODUCTS, INC.LGG2024-08-12
00840183517687BR Surgical, LLCBR Surgical, LLCLGG2024-03-14
00840183505738BR Surgical, LLCBR Surgical, LLCLGG2024-03-13
00888515326071BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
00888515326088BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.LGG2024-02-28
14026704722300KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
44026704722301KMEDICTELEFLEX INCORPORATEDLGG2024-02-16
00840183521196BR Surgical, LLCBR Surgical, LLCLGG2024-02-06
G586N5166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166340Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166370Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95166480Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95171160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95174160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95177160Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95182410Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
G586N95192310Novo SurgicalNOVO SURGICAL, INC.LGG2023-12-18
00842331194016Novo Surgical Inc. NOVO SURGICAL, INC.LGG2023-12-07
14026704722294KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
44026704722295KMEDICTELEFLEX INCORPORATEDLGG2023-10-13
00190776283667AvalignAvalign Technologies, Inc.LGG2023-09-28