FDA.reportPublic FDA data

AtriCure Atrial Rake

Primary DI
00818354014129
Brand
AtriCure Atrial Rake
Company
ATRICURE, INC.
Model
001-400-442
Device description
Atrial Rake - Medium
Published
2018-09-20
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
00818354014129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818354014129008183540141298183540141290818354014129

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

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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