Identity
- Trade Name
- K-BALL FDA UDI
- Generic Name
- CT phantom, test object FDA UDI
- Device Name
- K-BALL FDA UDI
- Model / Reference
- 01BK0001 FDA UDI
- Description
- K-BALL FDA UDI
Identifiers
- Catalog Number
- 01BK0001 FDA UDI
- Primary DI / UDI-DI
- 03701313007942 FDA UDI
- FDA Product Code
- JAC FDA UDI
- GMDN Term
- CT phantom, test object FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1640 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CT phantom, test object
K-Ball by S.m.a.i.o — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CT phantom, test object.
- Catphan® — Providus Holdings, Inc. · Class I
- Catphan® — Providus Holdings, Inc. · Class I
- Catphan® — Providus Holdings, Inc. · Class I
- Catphan® — Providus Holdings, Inc. · Class I
- ATCM Phantom — Providus Holdings, Inc. · Class I
- Catphan® — Providus Holdings, Inc. · Class I
- Catphan® — Providus Holdings, Inc. · Class I
- Catphan® — Providus Holdings, 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
- S.m.a.i.o
Sources (1)
- FDA UDI 3349c2eb-f523-4389-8128-c241aecc48d9 35 fields · synced May 31, 2026