AccessGUDID - DEVICE: Sterile Disposable Endocavity Needle Guide (00841912106615)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Disposable Endocavity Needle Guide
Version or Model: 5565
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5565
Company Name: PROTEK MEDICAL PRODUCTS, INC.

Primary DI Number: 00841912106615
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965417181 *Terms of Use

Device Description: Sterile Disposable Endocavity Needle Guide for use with Esaote EC123, EC1123, SE3123, SE3133, TRT12 & IVT12, GE Healthcare IC5-9-RS & IC5-9W-RS, Philips E6509, Siemens BE9-4, Samsung Medison BCC4-9, Pie Medical C7-4R8TRD and Terason 8EC4 Ultrasound Transducers

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
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971115	000
K971722	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: abc2e945-bc25-46f3-9f13-3cfdac72d163
Public Version Date: February 16, 2024
Public Version Number: 5
DI Record Publish Date: June 01, 2020