Identity
- Trade Name
- Integra® Jarit® FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- Integra® Jarit® VATS Suction Instrument, Variable Suction, Blunt Tip, Straight FDA UDI
- Model / Reference
- 323911 FDA UDI
- Description
- Integra® Jarit® VATS Suction Instrument, Variable Suction, Blunt Tip, Straight FDA UDI
Identifiers
- Catalog Number
- 323-911 FDA UDI
- Primary DI / UDI-DI
- 10381780130260 FDA UDI
- 510(k) Number
- K120012 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Suction system catheter, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDI
Category: Suction system catheter, general-purpose
Integra® Jarit® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction system catheter, general-purpose.
- Gen2 — SURGIX MEDICAL LLC · Class II
- Hayden Medical — Hayden Medical Inc · Class II
- Gen2 — SURGIX MEDICAL LLC · Class II
- GP General Purpose Drainage Catheter — Uresil Corp. · Class I
- Gen2 — SURGIX MEDICAL LLC · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Cleared under the same submission
K120012 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
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 26d95366-0e91-4504-b148-003075ff9b4f 37 fields · synced Jun 9, 2026