FDA UDI
In Commercial Distribution
🇺🇸 United States
Stoma Sizing Guide (50 pcs)
DI: 07331791015366
·
Model: 7135
·
Atos Medical AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
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Basic Information
- Brand Name
- Stoma Sizing Guide (50 pcs)
- Primary DI
- 07331791015366
- Version / Model
- 7135
- Catalog Number
- 7135
- Company Name
- Atos Medical AB
- Labeler DUNS
- 355470923
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-05
- Public Version
- 4
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- a9920523-1a35-41d5-8cba-14db4b085bd1
Device Description
Stoma Sizing Guide is a single use device intended to help the prescribing clinician determine which size of LaryTube or LaryButton in the Provox and Provox Life™ range respectively should be prescribed to the patient. Stoma Sizing Guide is intended to be used by a prescribing clinician who has read the IFU for Provox and Provox Life™ LaryTube and LaryButton respectively. Stoma Sizing Guide can also be used by patients to monitor the stoma size.
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 |
|---|---|---|---|---|
| 65811 | Tracheostoma sizer | An invasive device intended to assess the dimensions of a tracheostoma to help in the selection of an appropriately sized invasive tracheostomal appliance (e.g., laryngectomy tube). It is typically in the form of a shaped template designed to assess the internal tracheal anatomy and may additionally include a stoma diameter reference template. 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 | 07331791016783 | GS1 | ||||
| Primary | 07331791015366 | GS1 |
Customer Contacts
- Phone
- +4641519800
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain. Keep away from sunlight.
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 108 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 42 Degrees Celsius