FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gimmi
DI: 04049047545897
·
Model: T.0032.08
·
Gimmi GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gimmi
- Primary DI
- 04049047545897
- Version / Model
- T.0032.08
- Catalog Number
- T.0032.08
- Company Name
- Gimmi GmbH
- Labeler DUNS
- 316152610
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-05
- Public Version
- 4
- Public Version Date
- 2022-04-28
- Public Version Status
- Update
- Public Device Record Key
- a3b1f745-e3cc-4bf3-b9b8-d8ce9d105cb2
- Distribution End Date
- 2017-12-20
Device Description
SUCTION / IRRIGATION TUBE TUBE BLUNT WORKING LENGTH 330 MM
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38824 | General-purpose endoscopic needle, reusable | A flexible 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049047545897 | GS1 |
Customer Contacts
- Phone
- +497461965900
- [email protected]