FDA UDI
In Commercial Distribution
🇺🇸 United States
SonoTip® EBUS Pro Flex
DI: 04052838011495
·
Model: GUS-46-18-022
·
Medi-Globe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SonoTip® EBUS Pro Flex
- Primary DI
- 04052838011495
- Version / Model
- GUS-46-18-022
- Catalog Number
- GUS-46-18-022
- Company Name
- Medi-Globe GmbH
- Labeler DUNS
- 318130267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-30
- Public Version
- 3
- Public Version Date
- 2019-07-12
- Public Version Status
- Update
- Public Device Record Key
- 87838d33-957c-4a1d-b9ce-0945cbff0ba5
Device Description
SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Olympus Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8 mm, plastic sheath
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
- 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 |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35886 | Body aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04052838011488 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 04052838011495 | GS1 |
Customer Contacts
- Phone
- +4980329730
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 22 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, keep away from sunlight