AccessGUDID - DEVICE: AccuCARE Accessory Kit (00841436103046)

GUDID

Device Identifier (DI) Information

Brand Name: AccuCARE Accessory Kit
Version or Model: 610-1294
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 610-1294
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436103046
Issuing Agency: GS1
Commercial Distribution End Date: July 07, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Sterile 17GA grid (10), sterile (81.3 x 91.4cm) polyethylene drape (10), non-sterile (2 x 14cm) endocavity balloon (10) and sterile Aquasonic 20 gel packettes (10)

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:	Yes
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?
38426	Prostate brachytherapy system applicator, manual	A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic
JAQ	System, applicator, radionuclide, remote-controlled
IWJ	System, applicator, radionuclide, manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131161	000
K970513	000
K992152	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 3.5 Inch
Width: 3.2 Inch

Device Record Status

Public Device Record Key: b9dfe822-5f14-4f2c-aa9f-d849521539f7
Public Version Date: August 23, 2022
Public Version Number: 5
DI Record Publish Date: August 22, 2017