FDA UDI
In Commercial Distribution
🇺🇸 United States
Mediflex Universal Round Bar Table Mounted Retractor Systems
DI: 00842102109331
·
Model: 72107-R
·
FLEXBAR MACHINE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mediflex Universal Round Bar Table Mounted Retractor Systems
- Primary DI
- 00842102109331
- Version / Model
- 72107-R
- Company Name
- FLEXBAR MACHINE CORPORATION
- Labeler DUNS
- 047644935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-31
- Public Version
- 1
- Public Version Date
- 2019-03-04
- Public Version Status
- New
- Public Device Record Key
- 333eb25f-1b41-43e8-83be-ddaf9038b48f
Device Description
Univ. TMR Blade, Kelly 1 x 3" (2.5 x 7.6cm)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 47664 | Gastric contractility modulation system pulse generator | A hermetically-sealed, battery-powered device implanted beneath the skin and connected to implanted leads to monitor intrinsic electrical and mechanical gastric activity and deliver gastric contractility modulation (GCM) electrical signals to the stomach to help improve glycaemic control and induce weight loss typically in an obese patient with type 2 diabetes mellitus. The device is programmed by and transmits gastric diagnostic data to an external programmer telemetrically. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842102109331 | GS1 |