FDA.reportPublic FDA data

AtriCure SI Retractor Blade

Primary DI
00818354014006
Brand
AtriCure SI Retractor Blade
Company
ATRICURE, INC.
Model
001-400-173
Device description
SI Retractor Blade, 40mm W X 70mm L, Standard
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
00818354014006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818354014006008183540140068183540140060818354014006

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter
Width40Millimeter

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

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Primary DI, Brand, Model table
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10840143902697cryoICE® SystemA001150A001150-42026-05-27
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10840143902734cryoICE® SystemA001150A001150-82026-05-27
30840143904343cryoICE® SystemCMF1A0013592026-05-27
30840143912164AtriCure® cryoICE® BOXACM1A000896-52026-05-27
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