FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 10680651924909
·
Model: 92490
·
Avanos Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Halyard
- Primary DI
- 10680651924909
- Version / Model
- 92490
- Catalog Number
- 60109
- Company Name
- Avanos Medical, Inc.
- Labeler DUNS
- 079375431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-06
- Public Version
- 4
- Public Version Date
- 2018-11-16
- Public Version Status
- Update
- Public Device Record Key
- 829b5b7b-36fd-4692-aec0-cb40ee134874
Device Description
HALYARD* Biopsy Forcep
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 |
|---|---|---|---|---|
| KGE | FORCEPS, BIOPSY, ELECTRIC | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32638 | Flexible bronchoscopic biopsy forceps, single-use | A flexible manual instrument intended to perform through a compatible bronchoscope to obtain specimens of the bronchi and/or the lungs during endoscopy for histopathological examination. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like cups with a cutting edge around their rim which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651924903 | GS1 | CS | 5 | In Commercial Distribution | |
| Primary | 10680651924909 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K932790 | 000 |