FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AOS Flexiguide Needle
DI: 00850645007366
·
Model: NFW0001-010
·
ALPHA-OMEGA SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- AOS Flexiguide Needle
- Primary DI
- 00850645007366
- Version / Model
- NFW0001-010
- Company Name
- ALPHA-OMEGA SERVICES, INC.
- Labeler DUNS
- 060398989
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-10-05
- Public Version
- 5
- Public Version Date
- 2024-07-31
- Public Version Status
- Update
- Public Device Record Key
- 1c4d85fd-308f-4854-a702-d5fe1fa0eb7d
- Distribution End Date
- 2024-07-30
Device Description
Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, 25 cm, 10 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
- 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 |
|---|---|---|---|---|
| 38436 | General-purpose brachytherapy system applicator, remote-afterloading | A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850645007366 | GS1 | ||||
| Unit of Use | 00850645007830 | GS1 |