FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Provox Insertion System 20Fr
DI: 07331791010712
·
Model: 8018
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Provox Insertion System 20Fr
- Primary DI
- 07331791010712
- Version / Model
- 8018
- Catalog Number
- 8018
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 2
- Public Version Date
- 2023-06-14
- Public Version Status
- Update
- Public Device Record Key
- b06ad5ac-086a-4858-85e5-760df5461171
- Distribution End Date
- 2023-06-13
Device Description
The Provox Insertion System is intended for anterograde replacement of a Provox Vega Voice Prosthesis.
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62127 | Tracheoesophageal device introducer | A hand-held manual instrument designed to assist in the non-surgical placement of a tracheoesophageal device (e.g., speech valve, speech valve occluder, fistula gauge/dilator). It is a synthetic polymer holder onto which the tracheoesophageal device is distally mounted and directed to the target site through the tracheostoma. It is intended to be used by the patient at home (for non-indwelling devices) and clinician in the healthcare facility (for indwelling devices). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07331791010712 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, Keep away from sunlight