FDA UDI
In Commercial Distribution
🇺🇸 United States
AED Hystero Pro Cobra Grasper, 3mm x 36cm
DI: 00848657076128
·
Model: H1417
·
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AED Hystero Pro Cobra Grasper, 3mm x 36cm
- Primary DI
- 00848657076128
- Version / Model
- H1417
- Catalog Number
- H1417
- Company Name
- NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- Labeler DUNS
- 839138955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-23
- Public Version
- 1
- Public Version Date
- 2023-01-31
- Public Version Status
- New
- Public Device Record Key
- 378a0249-91e6-4934-be93-2ff2bb8c0fb3
Device Description
A semi-rigid forcep inserted through the working channel of an endoscope to grasp tissue or other foreign bodies. It has a lure port for cleaning.
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35524 | Flexible endoscopic tissue manipulation forceps, reusable | A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848657076128 | GS1 |
Customer Contacts
- Phone
- 8182272720
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141515 | 000 |