AccessGUDID - DEVICE: SmartFlow (00850359007430)

GUDID

Device Identifier (DI) Information

Brand Name: SmartFlow
Version or Model: NGS-NC-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NGS-NC-02
Company Name: Clearpoint Neuro, Inc.

Primary DI Number: 00850359007430
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119078557 *Terms of Use

Device Description: SmartFlow Neuro Cannula, 16 ga, .008" ID x 10 ft x 18mm tip

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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?
62753	Intracerebral cannula, nonimplantable, single-use	A sterile, nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCD	Cannula, Ventricular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102101	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b80555b4-7cf9-475f-b75b-d9c51c193cee
Public Version Date: March 22, 2024
Public Version Number: 6
DI Record Publish Date: January 22, 2021

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 949-900-6833
Email: quality@clearpointneuro.com

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