FDA.reportPublic FDA data

LiV™ Instruments

Primary DI
00818354013139
Brand
LiV™ Instruments
Company
ATRICURE, INC.
Model
001-300-700
Catalog number
N/A
Device description
LiV Instrument Sterilization Case
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818354013139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818354013139008183540131398183540131390818354013139

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
Height4Inch
Length20.5Inch
Width10Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
866-349-2342xxx@xxx.xxx

Regulatory Flags#

DUNS number
006133784
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840143913761Isolator Synergy™ OSL2A000432-122026-05-12
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO135A0008242026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO140A0008252026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO145A0008262026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO150A0008272026-04-28
10840143913488AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO235A0009652026-04-28
10840143913495AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO240A0009662026-04-28
10840143913501AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO245A0009672026-04-28
10840143913518AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO250A000968 2026-04-28
10840143913525AtriClip PROV® LAA Exclusion SystemPROV35A000971-42026-04-28
10840143913532AtriClip PROV® LAA Exclusion SystemPROV40A000972-42026-04-28
10840143913549AtriClip PROV® LAA Exclusion SystemPROV45A000973-42026-04-28
10840143913556AtriClip PROV® LAA Exclusion SystemPROV50A000974-42026-04-28
10840143914270AtriClip® FlexV® LAA Exclusion SystemACHV35A001017-42026-04-28
10840143914287AtriClip® FlexV® LAA Exclusion SystemACHV40A001018-42026-04-28
10840143914294AtriClip® FlexV® LAA Exclusion SystemACHV45A001019-42026-04-28
10840143914300AtriClip® FlexV® LAA Exclusion SystemACHV50A001020-42026-04-28
10840143907807EPi-Sense Guided Coagulation SystemCDK-1413CDK-1413-32026-04-23
10840143907845Subtle Cannula with Guide CSK-6130A001286-32026-04-23
10840143907852Cannula with GuideCSK-6131CSK-61312026-04-23

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