Hulka Clips 4986.09

GUDID 00861523000102

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

RICHARD WOLF MEDICAL INSTRUMENTS CORP.

Fallopian tube clip/band

• Primary Device ID: 00861523000102
• NIH Device Record Key: c64d66b5-5930-418f-aeb1-0804a52573eb
• Commercial Distribution Discontinuation: 2016-08-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Hulka Clips
• Version Model Number: 4986.90
• Catalog Number: 4986.09
• Company DUNS: 057842122
• Company Name: RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800)323-9653
• Email: customerservice@richardwolfusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861523000102 [Primary]
GS1	10861523000109 [Package]; Package: paper box [10 Units]; Discontinued: 2016-08-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P870080

FDA Product Code

• KNH: Device, Occlusion, Tubal, Contraceptive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-11