AccessGUDID - DEVICE: Hulka Clips (00861523000102)

GUDID

Device Identifier (DI) Information

Brand Name: Hulka Clips
Version or Model: 4986.90
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4986.09
Company Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.

Primary DI Number: 00861523000102
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 057842122 *Terms of Use

Device Description: Tubal Occluding Device in a sterile pouch (2 Hulka Clips per pouch)

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?
33598	Fallopian tube clip/band	An implantable device applied externally to the fallopian tube(s) to constrict the tube and prevent the passage of ova. It is typically used during tubal ligation procedures and functions as a contraceptive device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KNH	Device, Occlusion, Tubal, Contraceptive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P870080	002

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: c64d66b5-5930-418f-aeb1-0804a52573eb
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: November 11, 2014