AccessGUDID - DEVICE: Solitaire 2 (00836462016385)

GUDID

Device Identifier (DI) Information

Brand Name: Solitaire 2
Version or Model: SFR2-4-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Micro Therapeutics, Inc.

Primary DI Number: 00836462016385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 826110710 *Terms of Use

Device Description: SFR2-4-20 SOLITAIRE 2 DEVICE

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?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRY	CATHETER, THROMBUS RETRIEVER
POL	Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123378	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: Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 4 Millimeter
Length: 31 Millimeter
Device Size Text, specify: Usable Length,20,Millimeter;Push Wire Length,180,Centimeter;

Device Record Status

Public Device Record Key: 6dafcace-2a9d-4bec-abef-92c68c142d10
Public Version Date: November 09, 2022
Public Version Number: 7
DI Record Publish Date: October 16, 2015

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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