FDA UDI
In Commercial Distribution
🇺🇸 United States
Fidmi Low Profile Percutaneous Endoscopic Measuring Kit
DI: 07290018632000
·
Model: FG-MES
·
FIDMI MEDICAL LTD
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fidmi Low Profile Percutaneous Endoscopic Measuring Kit
- Primary DI
- 07290018632000
- Version / Model
- FG-MES
- Catalog Number
- FG-MES
- Company Name
- FIDMI MEDICAL LTD
- Labeler DUNS
- 600363369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-15
- Public Version
- 1
- Public Version Date
- 2021-08-23
- Public Version Status
- New
- Public Device Record Key
- 1f48e311-d256-44c8-8e70-cbd76449e67f
Device Description
The Fidmi Medical Stoma Measuring Device is a single use, sterile, disposable device used for the creation and themeasuring of a stoma tract for the choosing and placement of an appropriate Fidmi Medical Low-Profile Gastrostomy Tube. The Stoma Measuring Device is Packed with the components necessary to perform the procedure.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64462 | Gastrostomy procedure kit | A collection of surgical devices, which does not include a gastrostomy tube, intended to assist with a gastrostomy procedure (the surgical creation of a stoma into the stomach for placement of a gastrostomy tube). It typically includes devices dedicated to tube introduction/function (e.g., introduction needle, guidewire, dilator, fastener) with a surgical cutting device(s) intended to be used to perform the gastrostomy (e.g., scalpel). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018632000 | GS1 |