AccessGUDID - DEVICE: Open Needle Guide (00813079020424)

GUDID

Device Identifier (DI) Information

Brand Name: Open Needle Guide
Version or Model: LNGO-2022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LNGO-2022
Company Name: REMINGTON MEDICAL, INC.

Primary DI Number: 00813079020424
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 788472314 *Terms of Use

Device Description: 20/22ga (0.9/0.7mm)

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?
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

[?]

Product Code	Product Code Name
IZH	System, x-ray, mammographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K983621	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 22 Gauge

Device Record Status

Public Device Record Key: 520fc6a5-116d-4ce6-885f-ac6c16f9c1c4
Public Version Date: February 16, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2020