FDA UDI
In Commercial Distribution
🇺🇸 United States
M-Flex®
DI: 00816734020142
·
Model: 1206-48
·
DIVERSATEK HEALTHCARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- M-Flex®
- Primary DI
- 00816734020142
- Version / Model
- 1206-48
- Catalog Number
- 1206-48
- Company Name
- DIVERSATEK HEALTHCARE, INC.
- Labeler DUNS
- 030650113
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 7
- Public Version Date
- 2019-04-10
- Public Version Status
- Update
- Public Device Record Key
- efa396d5-87b8-4518-92e3-ec741c4ecdfe
Device Description
Blue Silicone Tungsten Maloney Esophageal Dilator, 48 French
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | Gastroenterology, Urology | 876.5365 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35052 | Oesophageal bougie, reusable | A cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816734020142 | GS1 |
Customer Contacts
- Phone
- 800-558-6408
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 48 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store flat, do not hang