FDA UDI
In Commercial Distribution
🇺🇸 United States
Halyard
DI: 10680651423013
·
Model: 42301
·
O&M HALYARD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Halyard
- Primary DI
- 10680651423013
- Version / Model
- 42301
- Catalog Number
- 42301-02
- Company Name
- O&M HALYARD, INC.
- Labeler DUNS
- 081057389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-15
- Public Version
- 4
- Public Version Date
- 2018-10-17
- Public Version Status
- Update
- Public Device Record Key
- f7add92b-d8aa-4a78-a9ea-f02b879d5876
Device Description
HALYARD* Standard Back Table Cover-No-44 x 88-44 x 88-Flat Fold-Individually Wrapped-28-1-28
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
- No
- 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 |
|---|---|---|---|---|
| KKX | Drape, surgical | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45021 | Instrument/equipment drape, single-use, sterile | A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30680651423017 | GS1 | CS | 28 | In Commercial Distribution | |
| Primary | 10680651423013 | GS1 |
Customer Contacts
- Phone
- +1(844)425-9273
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083234 | 000 |