FDA.report

Alligator

Primary DI
00836462014015
Brand
Alligator
Company
Micro Therapeutics, Inc.
Model
FA-88810-20
Catalog number
FA-88810-20
Device description
Retrieval Device
Published
2015-10-12
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
DQYCATHETER, PERCUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00836462014015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462014015008364620140158364620140150836462014015

GMDN Terms

TermDefinition
Medical device adhesive, sterileA sterile substance primarily used to promote the bonding of two surfaces in the manufacture of active implantable devices (e.g., pacing devices). After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Outer Diameter2Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods

Method

Contacts

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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