FDA UDI
In Commercial Distribution
🇺🇸 United States
Gimmi
DI: 04049047648185
·
Model: PU.1686.00
·
Gimmi GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Gimmi
- Primary DI
- 04049047648185
- Version / Model
- PU.1686.00
- Catalog Number
- PU.1686.00
- Company Name
- Gimmi GmbH
- Labeler DUNS
- 316152610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-20
- Public Version
- 1
- Public Version Date
- 2025-05-28
- Public Version Status
- New
- Public Device Record Key
- 510fa84c-d8e4-433d-9c98-9bab6e25a3e4
Device Description
ILLUMINATION BAR FOR MORGAN PROCTOSCOPE ONLY FOR PU.1685.02 - .10
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
- Yes
- 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 |
|---|---|---|---|---|
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15787 | Sphincteroscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anal sphincter. It is inserted into the body through the anus during a proctological procedure. The inserted portion is very short in length and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are usually viewed by direct vision. This device is used to examine/diagnose patients suffering abnormal functioning of the sphincter, internal haemorrhoids, or anal fissures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049047648185 | GS1 |
Customer Contacts
- Phone
- +497461965900
- [email protected]