FDA UDI
In Commercial Distribution
🇺🇸 United States
Provox TwistLock 17Fr
DI: 07331791012747
·
Model: 8030
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Provox TwistLock 17Fr
- Primary DI
- 07331791012747
- Version / Model
- 8030
- Catalog Number
- 8030
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2022-11-23
- Public Version
- 1
- Public Version Date
- 2022-12-01
- Public Version Status
- New
- Public Device Record Key
- 72956679-5a1e-4b49-b7c3-1b2edf090bca
Device Description
Provox TwistLock is a single use Provox Insertion System accessory for easier loading of Provox Vega Voice Prosthesis into Provox Capsule by clinician.
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 63307 | Tracheoesophageal speech valve capsule mounting cap | A non-sterile, noninvasive, non-patient-contact device intended to be used to help place a tracheoesophageal speech valve inside a dissolvable capsule designed for atraumatic insertion of the speech valve into a tracheoesophageal fistula (puncture). It is in the form of a small cylindrical cap into which the dissolvable capsule is loaded prior to insertion of the speech valve into the capsule. It is intended to be used by a clinician in a healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 07331791016295 | GS1 | ||||
| Primary | 07331791012747 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep away from sunlight