AccessGUDID - DEVICE: The Wand Universal Needle Guide Probe Cover Kit (00841912101450)

GUDID

Device Identifier (DI) Information

Brand Name: The Wand Universal Needle Guide Probe Cover Kit
Version or Model: 5444
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5444
Company Name: PROTEK MEDICAL PRODUCTS, INC.

Primary DI Number: 00841912101450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965417181 *Terms of Use

Device Description: No description.

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":	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?
43970	Cable/lead/sensor/probe cover, sterile	A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.	Obsolete	false
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
KKX	Drape, Surgical
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970889	000
K973958	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: 0ef01dc5-1060-4a58-8c49-64dc0b75e5f2
Public Version Date: February 16, 2024
Public Version Number: 9
DI Record Publish Date: September 16, 2016