Identity
- Trade Name
- Integra® Jarit® FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Integra® Jarit® Bipolar Cable, For Wolf Generator, 10' FDA UDI
- Model / Reference
- 615296B FDA UDI
- Description
- Integra® Jarit® Bipolar Cable, For Wolf Generator, 10' FDA UDI
Identifiers
- Catalog Number
- 615-296B FDA UDI
- Primary DI / UDI-DI
- 10381780129103 FDA UDI
- 510(k) Number
- K981919 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
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
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Integra® Jarit® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Bipolar Clamps — SUTTER MEDIZINTECHNIK GMBH · Class IIb
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- V. Mueller — STERIS CORPORATION · Class II
Cleared under the same submission
K981919 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Bipolar Connecting Cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
- Bipolar connecting cable — Spiggle & Theis Medizintechnik GmbH
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 II | Pending data |
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Manufacturer
- Manufacturer
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI 2e84aded-84bb-4b74-a773-57945ba1d69a 37 fields · synced Jun 9, 2026