Identity
- Trade Name
- BioPure FDA UDI
- Generic Name
- Dental irrigation/aspiration syringe FDA UDI
- Device Name
- BioPure MTAD Empty Syringes FDA UDI
- Model / Reference
- BPSYRNDL2 FDA UDI
- Description
- BioPure MTAD Empty Syringes FDA UDI
Identifiers
- Catalog Number
- BPSYRNDL2 FDA UDI
- Primary DI / UDI-DI
- D716BPSYRNDL21 FDA UDI
- FDA Product Code
- KJJ FDA UDI
- GMDN Term
- Dental irrigation/aspiration syringe FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental irrigation/aspiration syringe
BioPure by Tulsa Dental Products Llc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental irrigation/aspiration syringe.
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- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- CanalPro — Coltene/Whaledent Inc. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Tulsa Dental Products Llc
Sources (1)
- FDA UDI 465f40a7-ab29-4847-b086-093b1b9314a7 34 fields · synced May 30, 2026