AccessGUDID - DEVICE: Clear Guide SteriGRID (B201CGSG0)

GUDID

Device Identifier (DI) Information

Brand Name: Clear Guide SteriGRID
Version or Model: CGSG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CG-SG
Company Name: CLEAR GUIDE MEDICAL, INC.

Primary DI Number: B201CGSG0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965399905 *Terms of Use

Device Description: The device is a needle guide grid for image-guided transperineal procedures. The device is intended to guide needle placements during endorectal ultrasound and MR/CT-guided interventions. The device is intended for use in a clinical setting. The device is intended as a disposable accessory to Clear Guide TP Access Tool (CG-PAT)

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":	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

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	Active	false

FDA Product Code

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Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
IWJ	System, Applicator, Radionuclide, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234030	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

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Size Type Text
Needle Gauge: 14 Gauge

Device Record Status

Public Device Record Key: fc0f0ac8-8948-4002-9069-ef4f5b47945d
Public Version Date: January 20, 2025
Public Version Number: 1
DI Record Publish Date: January 10, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B201CGSG1	1	B201CGSG0	In Commercial Distribution	Unit Box
B201CGSG2	4	B201CGSG1	In Commercial Distribution	Packer Shelf Box
B201CGSG3	1	B201CGSG2	In Commercial Distribution	Mailer Box
B201CGSG4	16	B201CGSG2	In Commercial Distribution	Shipper Box