Identity
- Trade Name
- Exact Medical Manufacturing, Inc. FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Ultrasound Probe Cover 26cm x 1.5m (Sealed End) with Elastic Bands FDA UDI
- Model / Reference
- DEF2409 FDA UDI
- Description
- Ultrasound Probe Cover 26cm x 1.5m (Sealed End) with Elastic Bands FDA UDI
Identifiers
- Catalog Number
- DEF2409 FDA UDI
- Primary DI / UDI-DI
- 00850033380972 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Exact Medical Manufacturing, Inc. by Exact Medical Manufacturing — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Exact Medical Manufacturing
Sources (1)
- FDA UDI 2a2749b4-e01d-4fa2-9db1-d20c352e21c7 35 fields · synced May 31, 2026