FDA.reportPublic FDA data

AtriCure System Cart

Primary DI
30840143902127
Brand
AtriCure System Cart
Company
ATRICURE, INC.
Model
ASCC2
Catalog number
A000843
Device description
CRYO CART KIT ASSEMBLY - TWO TANK SUPPORTS
Published
2021-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMFStand, Instrument, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMFStand, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143902127PackageGS11In Commercial Distribution
00818354011920PreviousGS10
10840143904035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084014390212730840143902127
00818354011920008183540119208183540119200818354011920
1084014390403510840143904035

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trolleyA cart used to transport medical and surgical instruments, and sometimes sterile supplies, from a central supply station or sterilization department to appropriate areas of the hospital [e.g., the operating room (OR)]. In sterilizing departments the trolley may be used in the sterilizing process, and for sterilized instruments the cart may be designed to accommodate sterile wraps/packaging and/or cases. This trolley (cart) can be closed or open (open trolleys are usually covered with fabric during transport).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-35 Degrees Celsius54 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006133784
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840143912832Cannula with GuideCSK-6131CSK-6131-32026-05-31
10840143902666cryoICE® SystemA001150A001150-12026-05-27
10840143902673cryoICE® SystemA001150A001150-22026-05-27
10840143902680cryoICE® SystemA001150A001150-32026-05-27
10840143902697cryoICE® SystemA001150A001150-42026-05-27
10840143902703cryoICE® SystemA001150A001150-52026-05-27
10840143902710cryoICE® SystemA001150A001150-62026-05-27
10840143902727cryoICE® SystemA001150A001150-72026-05-27
10840143902734cryoICE® SystemA001150A001150-82026-05-27
30840143904343cryoICE® SystemCMF1A0013592026-05-27
30840143912164AtriCure® cryoICE® BOXACM1A000896-52026-05-27
30840143913703Multifunctional Ablation GeneratorMAGA0013722026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190015TOPCONANTONI CARLES SAHMF2026-06-01
00850020301638RelianceHAAG-STREIT USA, INC.HMF2026-05-29
05907642694435Refraction UnitMDT SP Z O OHMF2025-08-08
00850020301607RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301614RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301621RelianceHAAG-STREIT USA, INC.HMF2025-08-04
05907642694459Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694466Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694473Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694480Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694497Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694510Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694534Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694541Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694565Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694589Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694596Refraction UnitMDT SP Z O OHMF2025-07-16
00850020301584RelianceHAAG-STREIT USA, INC.HMF2025-05-21
00850020301539RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301546RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301553RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301560RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301577RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00628308210015LombartINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210022S4 OptikINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210039MarcoINNOVA Medical Ophthalmics IncHMF2025-02-20
G699Q90630EyeCheq KioskEYECHEQ INC.HMF2024-10-17
05907642694442Refraction UnitMDT SP Z O OHMF2024-06-14
00850053428616IS-5500TOPCON HEALTHCARE INCHMF2024-05-28
00850053428517IS-6500TOPCON HEALTHCARE INCHMF2024-05-17