Identity
- Trade Name
- Sheeted HealX FDA UDI
- Generic Name
- Radiological image marker, noninvasive, single-use FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627987231168 FDA UDI
- FDA Product Code
- FTY FDA UDI
- GMDN Term
- Radiological image marker, noninvasive, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological image marker, noninvasive, single-use
Sheeted HealX by Swift Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological image marker, noninvasive, single-use.
- MNAV FIDUCIAL MARKERS — IZI MEDICAL PRODUCTS LLC · Class II
- ONPOINT SPHERZ PASSIVE MARKER-12 PACK — IZI MEDICAL PRODUCTS LLC · Class II
- Fiducial Marker, Sterile — MONTERIS MEDICAL CORP · Class I
- ONPOINT SNAP SPHERZ 25PK — IZI MEDICAL PRODUCTS LLC · Class II
- MM-SPOT — Beekley Corporation · Class I
- MR grid — Beekley Corporation · Class I
- HealX — Swift Medical, 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
- Swift Medical, Inc.
Sources (1)
- FDA UDI 82f84898-facc-48c1-9a5c-ce9eabf62bb3 32 fields · synced May 30, 2026