n.a.

Basic Information

• Brand Name: n.a.
• Primary DI: 04048551103647
• Version / Model: 26188SA
• Company Name: Karl Storz GmbH & Co. KG
• Labeler DUNS: 315731430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c23f9bdd-05e6-439a-aa0b-742f73c49e33

Device Description

Traction Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60654	Neovaginoplasty tensioning device	A non-sterile device intended to be used during postoperative creation of a neovagina in the treatment of vaginal aplasia. It typically consists of a spring-loaded plate with thread attachments; it orientates extra-abdominally and is connected to a vaginal dilator via an implanted tensioning thread. Postsurgical, daily tensioning is intended to create the neovagina. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048551103647	GS1

Premarket Submissions

Submission Number	Supplement Number
K946359	000