FDA UDI
In Commercial Distribution
🇺🇸 United States
Gimmi
DI: 04049047546184
·
Model: T.0040.05
·
Gimmi GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gimmi
- Primary DI
- 04049047546184
- Version / Model
- T.0040.05
- Catalog Number
- T.0040.05
- Company Name
- Gimmi GmbH
- Labeler DUNS
- 316152610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-05
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 95937323-08a9-4449-90a0-e031289f458e
Device Description
GUIDE TUBE, CURVED, Ø 5 MM (FIT FOR T.0038.05)
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37149 | Laparoscopic dilation guide rod | A compact metal rod intended to be used during expansion of a laparoscopic access port (e.g., from 10 to 20 mm) by facilitating: 1) removal of an existing access cannula; and 2) introduction of a dilator/cannula assembly. It is inserted into the existing access cannula, keeping the opening airtight whilst the smaller access cannula is removed; a special dilator assembled with a larger access cannula is fed back over the guide rod. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049047546184 | GS1 |
Customer Contacts
- Phone
- +497461965900
- [email protected]