Identity
- Trade Name
- INTRABEAM® Flat Applicator Set 3.0 cm FDA UDI
- Generic Name
- Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator FDA UDI
- Model / Reference
- 304534-3001-567 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539101518 FDA UDI
- 510(k) Number
- K130549 FDA UDI
- FDA Product Code
- JAD FDA UDI
- GMDN Term
- Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5900 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.0 Centimeter FDA UDI
Category: Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator
INTRABEAM® Flat Applicator Set 3.0 cm by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative/postoperative therapeutic x-ray system intraoperative flat applicator.
- INTRABEAM® Flat Applicator Set 1.0 cm — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Flat Applicator Set 2.0 cm — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Flat Applicator Set 5.0 cm — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Flat Applicator Set 4.0 cm — Carl Zeiss Meditec AG · Class II
- INTRABEAM® Flat Applicator Set 6.0 cm — Carl Zeiss Meditec AG · Class II
Cleared under the same submission
K130549 also covers:
- INTRABEAM® Flat Applicator Set 1.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Flat Applicator Set 2.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Flat Applicator Set 4.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Flat Applicator Set 5.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Flat Applicator Set 6.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Surface Applicator Set 1.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Surface Applicator Set 2.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Surface Applicator Set 3.0 cm — Carl Zeiss Meditec AG
- INTRABEAM® Surface Applicator Set 4.0 cm — Carl Zeiss Meditec AG
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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 58185940-d303-4680-9f41-0778536e3a53 34 fields · synced May 30, 2026