FDA UDI
In Commercial Distribution
🇺🇸 United States
GammaPod™ Breast Immobilization and Localization System
DI: 10850002615293
·
Model: Inner Breast Cup
·
XCISION MEDICAL SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- GammaPod™ Breast Immobilization and Localization System
- Primary DI
- 10850002615293
- Version / Model
- Inner Breast Cup
- Catalog Number
- XMSGP030A10.02-019
- Company Name
- XCISION MEDICAL SYSTEMS, LLC
- Labeler DUNS
- 788286941
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2019-03-21
- Public Version
- 1
- Public Version Date
- 2019-03-29
- Public Version Status
- New
- Public Device Record Key
- 1e88efd0-6ce2-4537-8a54-976860304f6d
Device Description
M08
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IWB | System, Radiation Therapy, Radionuclide | Radiology | 892.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64181 | Stereotactic radiotherapy breast positioning system inner cup | A bowl-shaped component of a stereotactic radiotherapy breast positioning system intended to cover/fit onto a female breast, with direct patient contact, to facilitate reproducible positioning/immobilization during stereotactic radiotherapy (SRT) imaging and treatment. It is used in conjunction with an outer cup where a vacuum is formed between the two cups; it is typically made of polymers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10850002615293 | GS1 | ||||
| Unit of Use | 00850002615296 | GS1 |
Customer Contacts
- Phone
- 1-855-924-7466
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180571 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 790 | Milliliter |