FDA UDI
In Commercial Distribution
🇺🇸 United States
Axxent Surface Controller
DI: 00858012005526
·
Model: 750850
·
Icad, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Axxent Surface Controller
- Primary DI
- 00858012005526
- Version / Model
- 750850
- Catalog Number
- XP1200
- Company Name
- Icad, Inc.
- Labeler DUNS
- 108870254
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 770607f8-72fe-44b9-8714-c6e9c0baab9d
Device Description
Axxent Surface Controller
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | Radiology | 892.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38435 | General-purpose brachytherapy system applicator, manual | A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858012005526 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153570 | 000 |