FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096401059
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
P2903
Catalog number
00-1206-091-11
Device description
Standard Acetabular Reamer Bottom Tray 57mm/70mm
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
00840096401059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096401059008400964010598400964010590840096401059

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
00840096408690Viant Medical, LLCT15467T154672020-09-03
00840096408706Viant Medical, LLCT15468T154682020-09-03
00840096408713Viant Medical, LLCT15469T154692020-09-03
00840096408720Viant Medical, LLCT15470T154702020-09-03
00840096408737Viant Medical, LLCT15471T154712020-09-03
00840096408744Viant Medical, LLCT15472T154722020-09-03
00840096408751Viant Medical, LLCT15473T154732020-09-03
00840096408768Viant Medical, LLCT15474T154742020-09-03
00840096408775Viant Medical, LLCT15475T154752020-09-03
00840096408782Viant Medical, LLCT15476T154762020-09-03
00840096408799Viant Medical, LLCT15477T154772020-09-03
00840096408805Viant Medical, LLCT15478T154782020-09-03
00840096408812Viant Medical, LLCT15479T154792020-09-03
00840096408829Viant Medical, LLCT15480T154802020-09-03
00840096408836Viant Medical, LLCT15481T154812020-09-03
00840096408843Viant Medical, LLCT15482T154822020-09-03
00840096408850Viant Medical, LLCT15483T154832020-09-03
00840096408867Viant Medical, LLCT15484T154842020-09-03
00840096408874Viant Medical, LLCT15485T154852020-09-03
00840096408881Viant Medical, LLCT15486T154862020-09-03

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