AccessGUDID - DEVICE: AMPLATZ GOOSE NECK™ (00763000225391)

GUDID

Device Identifier (DI) Information

Brand Name: AMPLATZ GOOSE NECK™
Version or Model: SK400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EV3, INC

Primary DI Number: 00763000225391
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117446916 *Terms of Use

Device Description: SNARE SK400 MICRO SNARE V01

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17927	Intravascular extraction catheter-snare	A 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)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	Catheter, percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970668	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Store away from sunlight at room temperature in a dry place.
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2.3-3.0 FR
Device Size Text, specify: Loop Diameter 4 Millimeter
Device Size Text, specify: Snare Length 175 Centimeter
Catheter Inner Diameter: 0.53 Millimeter
Device Size Text, specify: Wire Diameter 0.46 Millimeter
Catheter Working Length: 150.0 Centimeter

Device Record Status

Public Device Record Key: 21cbab36-4fb6-4a7a-8314-99f0578e19ed
Public Version Date: July 08, 2021
Public Version Number: 2
DI Record Publish Date: October 16, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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