FDA UDI
In Commercial Distribution
🇺🇸 United States
HI-LINE XS
DI: 04046963408039
·
Model: GB763SU
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HI-LINE XS
- Primary DI
- 04046963408039
- Version / Model
- GB763SU
- Catalog Number
- GB763SU
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-23
- Public Version
- 1
- Public Version Date
- 2020-05-01
- Public Version Status
- New
- Public Device Record Key
- 5560afe6-6c7f-46f6-b0a3-ca6acaafeae8
Device Description
HI-LINE XS DISP.SPRAY NOZZLE III
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18033 | Surgical mist irrigation tip | A device that is designed to deliver a combined stream of air and mist to clear blood from a specific area of a surgical site. This device is a special perforated tip which can be affixed to an appropriate kind of tubing that delivers the rinsing fluids. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963408039 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]