FDA UDI
In Commercial Distribution
🇺🇸 United States
SonoTip Pro Control
DI: 04052838014144
·
Model: GUS-33-18-022-04
·
Medi-Globe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SonoTip Pro Control
- Primary DI
- 04052838014144
- Version / Model
- GUS-33-18-022-04
- Catalog Number
- GUS-33-18-022-04
- Company Name
- Medi-Globe GmbH
- Labeler DUNS
- 318130267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- c90f2ae3-83d4-4f58-939f-5318df02715c
Device Description
SonoTip ProControl Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheath Diameter 1.8 mm, round stylet
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10403 | Ultrasound aspiration biopsy procedure kit | A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 4052838014151 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 04052838014144 | 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
- Please store the instrument at room temperature, keep dry and avoid exposure to sunlight