FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PTeye Fiber Optic Probe
DI: 00865124000448
·
Model: PTeye-1
·
AiBiomed
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PTeye Fiber Optic Probe
- Primary DI
- 00865124000448
- Version / Model
- PTeye-1
- Company Name
- AiBiomed
- Labeler DUNS
- 079623223
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-10
- Public Version
- 4
- Public Version Date
- 2025-12-12
- Public Version Status
- Update
- Public Device Record Key
- 6fa0ab21-c03f-4cf7-bfe8-cf6335239870
- Distribution End Date
- 2025-02-28
Device Description
Fiber Optic Probe. Single Use. Sterile. 1 unit per package.
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QDF | Parathyroid Autofluorescence Detection Device | General, Plastic Surgery | 878.4550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63879 | Intraoperative parathyroid detection system probe | A hand-held component of an intraoperative parathyroid detection system designed to aid surgeons in recognizing parathyroid tissue during open surgical thyroidectomies and parathyroidectomies using near-infrared (NIR) light and auto-fluorescence. The probe consists of a fibreoptic element that emits non-ionizing radiation in the near IR range (NIR), and another fibreoptic detector element for collection and transmission of the fluorescence emitted by the tissue to a photo detector. It is used with a dedicated control unit (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00865124000448 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 140 Degrees Fahrenheit