FDA.reportPublic FDA data

X-celerator

Primary DI
00836462003026
Brand
X-celerator
Company
Micro Therapeutics, Inc.
Model
103-0601-300
Catalog number
103-0601-300
Device description
10 Exchange Hydrophilic Guidewire
Published
2015-10-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWIRE, GUIDE, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836462003026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462003026008364620030268364620030260836462003026

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
826110710
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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00763000980863Reservoir24106 C2025-08-03
00763000448929Pipeline TM Flex Embolization Device with Shield Technology TMPED2-325-182025-03-11
00763000448936Pipeline TM Flex Embolization Device with Shield Technology TMPED2-325-202025-03-11
00763000448943Pipeline TM Flex Embolization Device with Shield Technology TMPED2-325-252025-03-11
00763000448950Pipeline TM Flex Embolization Device with Shield Technology TMPED2-325-302025-03-11
00763000448967Pipeline TM Flex Embolization Device with Shield Technology TMPED2-325-352025-03-11
00763000448974Pipeline TM Flex Embolization Device with Shield Technology TMPED2-350-102025-03-11
00763000449001Pipeline TM Flex Embolization Device with Shield Technology TMPED2-350-162025-03-11
00763000449018Pipeline TM Flex Embolization Device with Shield Technology TMPED2-350-182025-03-11
00763000449025Pipeline TM Flex Embolization Device with Shield Technology TMPED2-350-202025-03-11
00763000449032Pipeline TM Flex Embolization Device with Shield Technology TMPED2-350-252025-03-11
00763000449049Pipeline TM Flex Embolization Device with Shield Technology TMPED2-350-302025-03-11
00763000449056Pipeline TM Flex Embolization Device with Shield Technology TMPED2-350-352025-03-11
00763000449063Pipeline TM Flex Embolization Device with Shield Technology TMPED2-375-102025-03-11
00763000449070Pipeline TM Flex Embolization Device with Shield Technology TMPED2-375-122025-03-11

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Primary DI, Brand, Company table
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