FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniBoard™ BTM
DI: 08719425704357
·
Model: UATB-BTM
·
MACROMEDICS B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OmniBoard™ BTM
- Primary DI
- 08719425704357
- Version / Model
- UATB-BTM
- Catalog Number
- 126140
- Company Name
- MACROMEDICS B.V.
- Labeler DUNS
- 489730120
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fc43f380-6d7c-470d-8fc7-18a797fbe8e2
Device Description
OmniBoard Breast Treatment Module
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40897 | Indexed-immobilization patient positioning system | A assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719425704357 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142420 | 000 |