AccessGUDID - DEVICE: Endocavity Balloon (00841436109079)

GUDID

Device Identifier (DI) Information

Brand Name: Endocavity Balloon
Version or Model: H46222LR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: H46222LR
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436109079
Issuing Agency: GS1
Commercial Distribution End Date: July 07, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Non-sterile (2 x 14cm) endocavity balloon for use with B-K Medical 8658 (8558) and 8848, Best® Sonalis™, GE Healthcare ERB, Hitachi Aloka Medical EUP-U533, UST 672.5/7.5, Siemens Endo-P II (on SONOLINE Adara/Prima ultrasound system) and Terason 8B48 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:	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?
60633	Body-orifice ultrasound imaging transducer cover, image-enhancement	A sheath containing an extraluminal pocket/balloon portion intended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging. 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 [?]
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
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 0.83 Inch
Length: 7.5 Inch

Device Record Status

Public Device Record Key: 162eb131-7683-423b-a17f-66dfc43ae787
Public Version Date: August 23, 2022
Public Version Number: 7
DI Record Publish Date: August 22, 2017