Bioteque America, Inc.

Basic Information

• Brand Name: Bioteque America, Inc.
• Primary DI: 00810142352284
• Version / Model: DT-B/L
• Company Name: Bioteque America, Inc.
• Labeler DUNS: 785179719
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-29
• Public Version: 1
• Public Version Date: 2025-06-06
• Public Version Status: New
• Public Device Record Key: fc4ed7b4-db8e-4aaf-8be6-92d62d1c092b

Device Description

Vaginal Dilator ,"DT-B/L"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDX	Dilator, Vaginal	Obstetrics/Gynecology	884.3900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11267	Vaginal dilator	A firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810142352284	GS1

Premarket Submissions

Submission Number	Supplement Number
K003380	000