FDA.reportPublic FDA data

NA

Primary DI
00724995096113
Brand
NA
Company
STERIS CORPORATION
Model
SC134050
Catalog number
SC134050
Device description
The 12 inch x 23 inch Solid Lid Container System is used with the Sterilization Container System.
Published
2016-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850289000MONARCH STERILIZATION CONTAINER SYSTEMMonarch Products, Inc.1985-08-15FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995096113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995096113007249950961137249950961130724995096113

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length23Inch
Width12Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
961394798
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995237059V. MuellerCD75CCD75C2026-09-24
00724995237066V. MuellerCD75CBLACKCD75CBLACK2026-09-24
00724995237073V. MuellerCD75CBLUECD75CBLUE2026-09-24
00724995237080V. MuellerCD75CGOLDCD75CGOLD2026-09-24
00724995237097V. MuellerCD75CGREENCD75CGREEN2026-09-24
00724995237103V. MuellerCD75CPURPLECD75CPURPLE2026-09-24
00724995237110V. MuellerCD75CREDCD75CRED2026-09-24
00724995237127V. MuellerCD76BCD76B2026-09-24
00724995237134V. MuellerCD76BBLACKCD76BBLACK2026-09-24
00724995237141V. MuellerCD76BBLUECD76BBLUE2026-09-24
00724995237158V. MuellerCD76BGOLDCD76BGOLD2026-09-24
00724995237165V. MuellerCD76BGREENCD76BGREEN2026-09-24
00724995237172V. MuellerCD76BPURPLECD76BPURPLE2026-09-24
00724995237189V. MuellerCD76BREDCD76BRED2026-09-24
00724995237196V. MuellerCD76CCD76C2026-09-24
00724995237202V. MuellerCD76CBLACKCD76CBLACK2026-09-24
00724995237219V. MuellerCD76CBLUECD76CBLUE2026-09-24
00724995237226V. MuellerCD76CGOLDCD76CGOLD2026-09-24
00724995237233V. MuellerCD76CGREENCD76CGREEN2026-09-24
00724995237240V. MuellerCD76CPURPLECD76CPURPLE2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26
00810194403699AiraAIRA, LLCFRG2026-08-26
00810194403712AiraAIRA, LLCFRG2026-08-26
00810194403729AiraAIRA, LLCFRG2026-08-26
00810194403736AiraAIRA, LLCFRG2026-08-26
08404535030853Brasseler USAPeter Brasseler Holdings, LLCFRG2026-08-21
10724995233386V. MuellerSteris CorporationFRG2026-08-21
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14