Identity
- Trade Name
- Evolution™ FDA UDI
- Generic Name
- Frame/rail/pole device holder FDA UDI
- Device Name
- Evolution™ Pole Mount Assembly with cm H2O and mmHg Rail with Laser Level and Negative Scale of -25 cm H2O /-18 mmHG and Line Level FDA UDI
- Model / Reference
- INS410 FDA UDI
- Description
- Evolution™ Pole Mount Assembly with cm H2O and mmHg Rail with Laser Level and Negative Scale of -25 cm H2O /-18 mmHG and Line Level FDA UDI
Identifiers
- Catalog Number
- INS410 FDA UDI
- Primary DI / UDI-DI
- 10381780112242 FDA UDI
- 510(k) Number
- K062599 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Frame/rail/pole device holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Frame/rail/pole device holder
Evolution™ by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062599 also covers:
- BioPatch® — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
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 Corp.
Sources (1)
- FDA UDI 55fc0daf-3d89-462d-a27f-6b13d9867904 36 fields · synced May 31, 2026