FDA UDI
In Commercial Distribution
🇺🇸 United States
AIR BARRIER SYSTEM STERILE NOZZLE
DI: 00842430115448
·
Model: 160-0028
·
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AIR BARRIER SYSTEM STERILE NOZZLE
- Primary DI
- 00842430115448
- Version / Model
- 160-0028
- Catalog Number
- 600-0015
- Company Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Labeler DUNS
- 084527241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-19
- Public Version
- 7
- Public Version Date
- 2022-02-02
- Public Version Status
- Update
- Public Device Record Key
- c3b07fe5-0e86-493f-ae6c-8a0e27e592c5
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| ORC | Air Filter Portable Apparatus | General, Plastic Surgery | 878.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65101 | Surgical laminar airflow unit nozzle | A device designed to be connected to a surgical laminar airflow unit to channel filtered air directly to the site of operation during a surgical intervention to provide an area free of contaminants and reduce the risk of patient infection. It is in the form of a tubing hose with a distal nozzle that is typically adhered to the patient’s skin in proximity to the surgical wound to direct air across the site. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842430115448 | GS1 | ||||
| Package | 10842430115445 | GS1 | case | 5 | In Commercial Distribution | |
| Previous | 00869284000201 | GS1 |
Customer Contacts
- Phone
- 1-800-777-4674
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123006 | 000 |