FDA.report

SilverHawk

Primary DI
00821684043318
Brand
SilverHawk
Company
Covidien LP
Model
FG02550
Catalog number
FG02550
Device description
Cutter Driver for Plaque Excision Systems
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MCWCatheter, peripheral, atherectomy

Product Code Classifications

CodeDeviceSpecialtyClass
MCWCatheter, Peripheral, AtherectomyCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821684043318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684043318008216840433188216840433180821684043318

GMDN Terms

TermDefinition
Mechanical atherectomy system catheter, peripheralA sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of peripheral arteries. It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This device is not intended for use in the coronary, carotid, iliac or renal vasculature. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure0.7 KiloPascal1.06 KiloPascal
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure0.7 KiloPascal1.06 KiloPascal
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
968903703
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06975417183889PantherisZylox-Tonbridge Medical Technology Co., Ltd.MCW2026-03-21
00857141005322Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
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00857141005346Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005377Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005384Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005391Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
00857141005407Revolution Peripheral Atherectomy SystemRex Medical, Inc.MCW2025-12-16
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