AccessGUDID - DEVICE: Sterile Disposable Endocavity Needle Guide Kit (00841912105267)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Disposable Endocavity Needle Guide Kit
Version or Model: 9005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9005
Company Name: PROTEK MEDICAL PRODUCTS, INC.

Primary DI Number: 00841912105267
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 Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R10, International Biomedical E717, Kretz PB-ER4-9ES, Mindray EV6.5 MHZ/R10, 6CV1, 6CV1s, 65EC10EA, 65EC10EB, 65EC10HA, CB10-4, CB10-HS, V10-4, V10-4B, V10-4BS, V10-4S, V11-3E, V11-3WE & V11-3WS,Samsung Medison EC4-9IS, EC4-9ES, ER4-9ES, & 10R EV/140D, Siemens 6.5 EC10, EC7, EC9-4 (Sonoline G20, G50S & Acuson X500 Ultrasound Systems), & EV9-4 (Acuson X500 Ultrasound System), Supersonic Imagine SuperEndocavity SE12-3 & SEV12-3, Terason 8EC4(V), Vermon E710, and Zonare E9-3

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?
60608	Body-orifice ultrasound imaging transducer cover, basic	A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.	Active	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
ITX	Transducer, Ultrasonic, Diagnostic
KKX	Drape, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970893	000
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: 52d3643d-6b98-4b04-a4c8-873a5a187f63
Public Version Date: February 16, 2024
Public Version Number: 12
DI Record Publish Date: September 22, 2017