Bioteque America, Inc.

GUDID 00810142352253

Vaginal Dilator set-A, SET DT-A

Bioteque America, Inc.

Vaginal dilator

• Primary Device ID: 00810142352253
• NIH Device Record Key: b37e81e0-c076-4b05-be4d-edbc5728e9e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioteque America, Inc.
• Version Model Number: DT-A
• Company DUNS: 785179719
• Company Name: Bioteque America, Inc.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810142352253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003380

FDA Product Code

• HDX: Dilator, Vaginal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-16
• Device Publish Date: 2025-05-08

On-Brand Devices [Bioteque America, Inc.]

• 00810142350020: R2
• 00810142352369: Preferred Curette Sureflex
• 00810142352253: Vaginal Dilator set-A, SET DT-A
• 00810142350747: DISH PESSARY (w/o), DSH50 #0
• 00810142350228: CUBE PESSARY (w/o) ,CU33 #2