Identity
- Trade Name
- PMT® Halo Systems FDA UDI
- Generic Name
- Vascular implant detacher, electronic, single-use FDA UDI
- Device Name
- HALO, 1203-5 VEST X-LARGE, COOLMAX LINER, 1201-1 X-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W/ PEDIATRIC ANGLE BLOCKS FDA UDI
- Model / Reference
- 1206-179 FDA UDI
- Description
- HALO, 1203-5 VEST X-LARGE, COOLMAX LINER, 1201-1 X-LARGE CLOSED BACK RING, 1206-25 HEADBLOCKS, W/ PEDIATRIC ANGLE BLOCKS FDA UDI
Identifiers
- Catalog Number
- 1206-179 FDA UDI
- Primary DI / UDI-DI
- 00650551135418 FDA UDI
- 510(k) Number
- K090733 FDA UDI
- FDA Product Code
- HAX FDA UDI
- GMDN Term
- Vascular implant detacher, electronic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5960 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Vascular implant detacher, electronic, single-use
PMT® Halo Systems by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular implant detacher, electronic, single-use.
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Cleared under the same submission
K090733 also covers:
- PMT CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt Corp.
- PMT® CORPORATION HALO — Pmt 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
- Pmt Corp.
Sources (1)
- FDA UDI e08c49fb-b4ee-4583-a0d2-34c452bb9892 37 fields · synced Jun 1, 2026