Safetex

Basic Information

• Brand Name: Safetex
• Primary DI: 00187207000238
• Version / Model: 890076
• Company Name: Andwin Scientific
• Labeler DUNS: 028449445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-11-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: dd066217-d2cf-4c30-8054-867a873997d2

Device Description

SCRAPER, PLASTIC 8" SAFETEX DOUBLE ENDED (100)

Device Characteristics

• Single Use: Yes
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHT	Spatula, Cervical, Cytological	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32679	Cervical cytology scraper, single-use	A hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00187207000238	GS1
Unit of Use	10187207000235	GS1
Package	20187207000232	GS1	CASE	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K983428	000