FDA UDI
In Commercial Distribution
🇺🇸 United States
Click-Tip
DI: 04052838015684
·
Model: 06-19-230
·
Medi-Globe GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Click-Tip
- Primary DI
- 04052838015684
- Version / Model
- 06-19-230
- Catalog Number
- 06-19-230
- Company Name
- Medi-Globe GmbH
- Labeler DUNS
- 318130267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 97e1fe0f-47fa-4b8c-b694-914b7f6edaaa
Device Description
Click-Tip Injection Needle, 25 G, Needle Length 6 mm, Catheter Diameter 1.9 mm, Sheath Length 230 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
- 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
- No
- 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 |
|---|---|---|---|---|
| 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 | 4052838015691 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 04052838015684 | GS1 |
Customer Contacts
- Phone
- +4980329730
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and avoid exposure to sunlight and chemical fumes
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius