FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hayden Medical
DI: 00840319756966
·
Model: 405-470
·
Hayden Medical, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hayden Medical
- Primary DI
- 00840319756966
- Version / Model
- 405-470
- Catalog Number
- 405-470
- Company Name
- Hayden Medical, Inc.
- Labeler DUNS
- 618214410
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-12
- Public Version
- 2
- Public Version Date
- 2026-04-23
- Public Version Status
- Update
- Public Device Record Key
- 5afb9d35-5733-405e-bf24-f3a806c340b1
- Distribution End Date
- 2026-04-22
Device Description
Full HD Camera System w/ Integrated Monitor and Light Source, 1080p resolution w/ touchscreen
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34540 | Endoscopic video image processing/light source system | A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope. | No | Active |
| 35958 | Endoscope video camera | An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840319756966 | GS1 |
Customer Contacts
- Phone
- 6612967200
- [email protected]