FDA.reportPublic FDA data

AMPLATZ GOOSE NECK

Primary DI
00821684005019
Brand
AMPLATZ GOOSE NECK
Company
Covidien LP
Model
SK200
Device description
Microsnare Kit
Published
2015-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970668000THE AMPLANTZ GOOSE NECK MICROSNAREMicrovena Corp.1998-06-10DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684005019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684005019008216840050198216840050190821684005019

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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length175Centimeter
Outer Diameter0.018Inch
Outer Diameter2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep 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
968903703
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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10884521861114Vital SyncVITALSYNCSW032026-10-25
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
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08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
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