NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207045138
• Version / Model: 8991025
• Catalog Number: 8991.025
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 4
• Public Version Date: 2023-05-26
• Public Version Status: Update
• Public Device Record Key: f16ae31e-9810-4c66-a704-519669cd580f
• Distribution End Date: 2018-11-30

Device Description

AMNIOSCOPE TUBE ID 28.7MM OD 32/42MM for adults, TL 140mm, distal end straight, graduated, reusable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEZ	ENDOSCOPE, TRANSCERVICAL (AMNIOSCOPE)(AND ACCESSORIES)	Obstetrics/Gynecology	884.1660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32631	Transcervical amnioscope	An endoscope with a rigid inserted portion intended for the visual examination of the foetus while in the amnion (the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid). It is inserted via the vagina, through the maternal uterine cervix and into the amniotic cavity. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is typically used to examine the foetus for external malformations, to obtain foetal blood or tissue samples, and for the observation of the colour and volume of amniotic fluid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207045138	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	28.7	Millimeter