FDA.reportPublic FDA data

AlligatorTM

Primary DI
00847536014039
Brand
AlligatorTM
Company
Micro Therapeutics, Inc.
Model
FA-88810-50
Device description
FA-88810-50 ALLIGATOR DEVICE ARD 5MM
Published
2016-04-05
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536014039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536014039008475360140398475360140390847536014039

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter-snareA sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid temperature extremes, keep dry, keep away from sunlight

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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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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