FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 10680651927641
·
Model: 92764
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Halyard
- Primary DI
- 10680651927641
- Version / Model
- 92764
- Catalog Number
- 60634
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-20
- Public Version
- 4
- Public Version Date
- 2018-11-16
- Public Version Status
- Update
- Public Device Record Key
- e7f99061-2571-465d-a63d-1a58a0e925c5
Device Description
HALYARD* Foreign Body Grasping Forceps
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
- 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 |
|---|---|---|---|---|
| OCZ | Endoscopic grasping/cutting instrument, non-powered | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46685 | Flexible endoscopic stone-retrieval forceps, single-use | A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a flexible metal coil or plastic tube whose distal end is equipped with a pair of thin grasping claws in which the stone is seized and held for extraction. The claws are operated by a control handle at the proximal end of the instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651927645 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 10680651927641 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K874004 | 000 |