Identity
- Trade Name
- Paul Banditt FDA UDI
- Generic Name
- Periotome, reusable FDA UDI
- Device Name
- PAUL BANDITT TAPPING LUXATOR, 2.5MM, CURVED FDA UDI
- Model / Reference
- SVS41 FDA UDI
- Description
- PAUL BANDITT TAPPING LUXATOR, 2.5MM, CURVED FDA UDI
Identifiers
- Primary DI / UDI-DI
- D955SVS411 FDA UDI
- FDA Product Code
- EMJ FDA UDI
- GMDN Term
- Periotome, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Periotome, reusable
Paul Banditt by Terlain Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Periotome, reusable.
- Luxator — Directa AB · Class I
- A. Titan Instruments — A.Titan Instruments · Class I
- devemed — devemed GmbH · Class I
- STOMA® — Storz am Mark GmbH · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Power Dental USA — Power Dental USA, 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Terlain Enterprises, Inc.
Sources (1)
- FDA UDI 1fd68a0b-0e33-403f-abf9-909eb176740a 33 fields · synced May 31, 2026