FDA UDI
In Commercial Distribution
🇺🇸 United States
Cervical Applicator Set, Bundle 1
DI: 00858012005533
·
Model: 710850
·
Icad, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cervical Applicator Set, Bundle 1
- Primary DI
- 00858012005533
- Version / Model
- 710850
- Catalog Number
- CG1001
- Company Name
- Icad, Inc.
- Labeler DUNS
- 108870254
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 95408edf-0128-41d8-836f-0cdcd2a66261
Device Description
Cervical Applicator Bundle 1
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
- MR Safe
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | Radiology | 892.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38408 | Cervical/intrauterine brachytherapy system applicator, manual | A manual brachytherapy applicator specifically designed to be used in cervical and/or intrauterine radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging system guided placement, of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes cervical/intrauterine applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858012005533 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123442 | 000 |