FDA UDI
In Commercial Distribution
🇺🇸 United States
AOS Rectal Template, Syed/Neblett
DI: 00850645007496
·
Model: TRD0001-017
·
ALPHA-OMEGA SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AOS Rectal Template, Syed/Neblett
- Primary DI
- 00850645007496
- Version / Model
- TRD0001-017
- Company Name
- ALPHA-OMEGA SERVICES, INC.
- Labeler DUNS
- 060398989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-04
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4b3a664d-e881-4243-9bb1-e4de032c57f8
Device Description
Template, Syed/Neblett/Hedger, Series-17, Rectal, (36 Holes), Blue, 1 ea
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]
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 |
|---|---|---|---|---|
| 38431 | Anorectal brachytherapy system applicator, remote-afterloading | A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the rectum and/or anus. It is designed for temporary implantation within the rectum and/or anus and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of anorectal applicators, e.g., hollow needles, tubes, or catheters, and their associated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850645007496 | GS1 |