FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04038653423507
·
Model: PV423
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04038653423507
- Version / Model
- PV423
- Catalog Number
- PV423
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 749eaf85-10ab-4bf8-b565-44b8f3acf8c7
Device Description
3 CHIP CAMERA HEAD W/CABLE DIGITAL NTSC
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
- No
- PM Exempt
- No
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FET | Endoscopic video imaging system/component, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32259 | Endoscope cine camera | An electro-optical device that is designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to obtain moving-picture documentation of endoscopic findings and procedures. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It records a sequence of photographs and usually projects them sequentially to obtain a motion picture. The device may also include audio recording capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653423507 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]