AccessGUDID - DEVICE: Smit cervical sleeve 40 mm, with clamping for guiding tube (00816389021839)

GUDID

Device Identifier (DI) Information

Brand Name: Smit cervical sleeve 40 mm, with clamping for guiding tube
Version or Model: GM11000960
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GM11000960
Company Name: Varian Medical Systems Deutschland GmbH

Primary DI Number: 00816389021839
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332474605 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
Prescription Use (Rx):	No
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?
38407	Vaginal brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in vaginal or transvaginal radiation therapy treatments. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the vaginal area. This GMDN code includes a variety of applicators, e.g., hollow needles or tubes and catheters, and their associated components.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAQ	System, applicator, radionuclide, remote-controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033371	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 40 Millimeter

Device Record Status

Public Device Record Key: b662004e-e0e5-4bb0-8918-102dbdcbee36
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016