Identity
- Trade Name
- Integra® Jarit® FDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- Integra® Jarit® Seldin Elevator, 6", No. 4R FDA UDI
- Model / Reference
- 835543 FDA UDI
- Description
- Integra® Jarit® Seldin Elevator, 6", No. 4R FDA UDI
Identifiers
- Catalog Number
- 835-543 FDA UDI
- Primary DI / UDI-DI
- 10381780207139 FDA UDI
- FDA Product Code
- EMJ FDA UDI
- GMDN Term
- Dental elevator, tooth/root 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Inch FDA UDI
Category: Dental elevator, tooth/root
Integra® Jarit® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental elevator, tooth/root.
- ROOT ELEVATOR HEIDBRINK #3 EH-LG S/E — W.H. Holden, Inc. · Class I
- ELEVATOR #107 — W.H. Holden, Inc. · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
- Paul Banditt — Terlain Enterprises, 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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI ebb936c1-2066-4117-93ea-ab30b8102c69 36 fields · synced Jun 9, 2026