REEF HP

Primary DI
08033477049038
Brand
REEF HP
Company
MEDTRONIC, INC.
Model
REE040020082
Device description
Cath REE040020082 REEUS 04.00 L020UL0800
Published
2016-06-19
Public version status
Update
Distribution status
Not 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
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications

CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033477049038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033477049038080334770490388033477049038

GMDN Terms

TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.

Device Sizes

TypeValueUnit
Length20Millimeter
Outer Diameter4Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g. alcohol), ionizing radiation or ultraviolet light.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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