AccessGUDID - DEVICE: NA (00852073002845)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Two-Tap Shapeable HS Catheter, 7F
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TMI1184
Company Name: C R I

Primary DI Number: 00852073002845
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 130814890 *Terms of Use

Device Description: Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based contrast media

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?
18746	Intrauterine imaging medium catheter	A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKF	Cannula, Manipulator/Injector, Uterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032835	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
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 7 French
Length: 28 Centimeter

Device Record Status

Public Device Record Key: a62bc5d2-94a6-4ba4-b99a-b50077196781
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 30, 2016