FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox® XtraFlange™
DI: 07331791006944
·
Model: 17 Fr
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Provox® XtraFlange™
- Primary DI
- 07331791006944
- Version / Model
- 17 Fr
- Catalog Number
- 7277
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-11
- Public Version
- 4
- Public Version Date
- 2020-06-19
- Public Version Status
- Update
- Public Device Record Key
- 91903556-90eb-4baa-9b89-a08e919a5e0b
Device Description
Provox XtraFlange is a white silicone washer that is intended to be placed between the tracheal flange of the prosthesis and the tracheal mucosa. It provides an extra seal against periprosthetic leakage through the adherence of the thin silicone sheet to the tracheal mucosa. The device is supplied sterile and is intended for single use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EWL | Prosthesis, Laryngeal (Taub) | Ear, Nose, Throat | 874.3730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42533 | Tracheoesophageal speech valve, indwelling | A device designed to be inserted into a surgically-created tracheo-oesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced on an as needed basis by a speech pathologist or clinician. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). The patient periodically cleans the device in situ. Disposable devices associated with implantation/insertion may be included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07331791006944 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092593 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 5.6 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight.