AtriCure Window Access SI Retractor

Primary DI
00818354013979
Brand
AtriCure Window Access SI Retractor
Company
ATRICURE, INC.
Model
001-400-150
Catalog number
N/A
Device description
Window Access SI Retractor Body, Robotic 120mm
Published
2018-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00818354013979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00818354013979008183540139798183540139790818354013979

GMDN Terms

TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Device Sizes

TypeValueUnit
Length120Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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