FDA.report

Over-the-Wire LeMaitre Valvulotome

Primary DI
00840663100149
Brand
Over-the-Wire LeMaitre Valvulotome
Company
LEMAITRE VASCULAR, INC.
Model
e1005-00
Catalog number
e1005-00
Device description
2.0mm Over-the-Wire LeMaitre Valvulotome, 100 cm, eIFU
Published
2015-06-30
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
MGZValvulotome

Product Code Classifications

CodeDeviceSpecialtyClass
MGZValvulotomeCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840663100149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663100149008406631001498406631001490840663100149

GMDN Terms

TermDefinition
ValvulotomeA hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
781-221-2266xx@xx.xx

Regulatory Flags

DUNS number
184805166
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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