FDA UDI
In Commercial Distribution
🇺🇸 United States
Injectra, Sclero Tip
DI: 04052838009393
·
Model: GSN-01-19-180
·
Medi-Globe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Injectra, Sclero Tip
- Primary DI
- 04052838009393
- Version / Model
- GSN-01-19-180
- Catalog Number
- GSN-01-19-180
- Company Name
- Medi-Globe GmbH
- Labeler DUNS
- 318130267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-15
- Public Version
- 1
- Public Version Date
- 2019-05-23
- Public Version Status
- New
- Public Device Record Key
- cce8e463-97d5-457e-b77d-2c1d4567bf69
Device Description
Injection Needle / Slerotherapy Needle , 22 Gauge, needle length 4 mm, tube diameter 1.9 mm, working length 180 cm
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 |
|---|---|---|---|---|
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38825 | General-purpose endoscopic needle, single-use | A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04052838009409 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 04052838009393 | 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