AccessGUDID - DEVICE: ClearPath (00860000321334)

GUDID

Device Identifier (DI) Information

Brand Name: ClearPath
Version or Model: AK-19-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Clearmind Biomedical Inc.

Primary DI Number: 00860000321334
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658832644 *Terms of Use

Device Description: ClearPath Disposable Introducer

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:	No
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?
61440	Intracerebral trocar blade	A sterile, hand-held, manual surgical instrument with a sharp, needle-like point intended to be used in conjunction with an intracerebral catheter (e.g., ventricular catheter) to puncture tissue and create a channel to access the brain (e.g., cerebral ventricles, cystic tumours) typically for cerebrospinal fluid (CSF) drainage or infusion of materials (e.g., chemotherapeutic agents). It is inserted within the lumen of the intracerebral catheter prior to catheter insertion; the catheter is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWG	Endoscope, Neurological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210251	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: c1d400c9-de88-4fc5-9f04-7e01ba7afae8
Public Version Date: February 28, 2022
Public Version Number: 1
DI Record Publish Date: February 18, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00860000321341	5	00860000321334		In Commercial Distribution	Box
00860000321358	8	00860000321341		In Commercial Distribution	Carton

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

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES