FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRABEAM Spherical Sizer Set
DI: 04049539105509
·
Model: 309121-9100-000
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INTRABEAM Spherical Sizer Set
- Primary DI
- 04049539105509
- Version / Model
- 309121-9100-000
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 342228620
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-20
- Public Version
- 1
- Public Version Date
- 2025-06-30
- Public Version Status
- New
- Public Device Record Key
- b91c9230-96b8-4c26-83b5-adcbcf7cfd5f
Device Description
The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therapy. It shall be used to assess which INTRABEAM SMART Spherical Applicator, or INTRABEAM Spherical Applicator, shall be used for the given radiation therapy treatment using INTRABEAM system, based on the dimensions of the treatment location (intracavitary or intraoperative). It shall be used only with an INTRABEAM device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | Radiology | 892.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67544 | Intraoperative/postoperative therapeutic x-ray system applicator sizer | A manual surgical instrument intended to be used with an intraoperative/postoperative therapeutic x-ray system to aid selection of an appropriately sized x-ray irradiation applicator to a resected tumour bed, during radiation therapy procedures (e.g., breast cancer treatment). It mimics the distal end shape of the applicator (e.g., spherical) and is available as a set of graduated sizes, thus providing an estimated volume measurement of the tumour bed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049539105509 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241174 | 000 |