FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403426285
Brand
V. Mueller
Company
STERIS CORPORATION
Model
ED1-3
Catalog number
ED13
Device description
GENESIS COLOR END PLATE TOP, BROWN DUAL ACTION LATCH
Published
2016-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844652000C.A.S.E. CONTAINERGeneral Medical Co.1984-12-12FSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403426285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540342628510885403426285

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
10885403015960V. MuellerBP0-1ABP01A2017-11-17
10885403015977V. MuellerBP0-2ABP02A2017-11-17
10885403015991V. MuellerBP0-2VBP02V2017-11-17
10885403016004V. MuellerBP1-1ASBP11AS2017-11-17
10885403016011V. MuellerBP1-2ABP12A2017-11-17
10885403016035V. MuellerBP1-2ASBP12AS2017-11-17
10885403016066V. MuellerBP1-2VBP12V2017-11-17
10885403016073V. MuellerBP1-2VSBP12VS2017-11-17
10885403016080V. MuellerBP1-3ABP13A2017-11-17
10885403016103V. MuellerBP1-3VBP13V2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606192002Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192019Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192026Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192033Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192040Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194884Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194891Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194907Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194914Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194921Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194938Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194945Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194952Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194969Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194976Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194983Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194990Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195003Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195010Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195027Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195034Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195041Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195058Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195065Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195539Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195669Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195676Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195683Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195690Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195706Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31