FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096401066
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
P2904
Catalog number
00-1206-091-16
Device description
Jumbo Acetabular Reamer Bottom Tray 71mm/80mm
Published
2020-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096401066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096401066008400964010668400964010660840096401066

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
100512072
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840096400045Viant Medical, LLC5111725111722020-09-29
00840096400069Viant Medical, LLCT17651T176512020-09-29
00840096403848Viant Medical, LLC5112725112722020-08-08
00840096403855Viant Medical, LLC5112735112732020-08-08
00840096401011Viant Medical, LLC5109125109122020-05-14
00840096401127Viant Medical, LLCT10491T104912020-05-14
00840096401141Viant Medical, LLCT12230T122302020-05-14
00840096401158Viant Medical, LLCT14174T141742020-05-14
00840096401165Viant Medical, LLCT14331T143312020-05-14
00840096401172Viant Medical, LLCT15752T157522020-05-14
00840096401189Viant Medical, LLCT16611T166112020-05-14
00840096401196Viant Medical, LLCT17703T177032020-05-14
00840096401233Viant Medical, LLCT8044T80442020-05-14
00840096401240Viant Medical, LLCT8088T80882020-05-14
00840096401257Viant Medical, LLCT8143T81432020-05-14
00840096401271Viant Medical, LLCT8177T81772020-05-14
00840096401288Viant Medical, LLCT8468T84682020-05-14
00840096401295Viant Medical, LLCT9316T93162020-05-14
00840096401042Viant Medical, LLCP290200-1206-091-122020-10-23
00840096401059Viant Medical, LLCP290300-1206-091-112020-10-23

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Primary DI, Brand, Company table
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ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
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