FDA UDI
In Commercial Distribution
🇺🇸 United States
Shaver System
DI: 00857326005833
·
Model: SSB-12200-1, SSB-12200-5
·
ENTELLUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Shaver System
- Primary DI
- 00857326005833
- Version / Model
- SSB-12200-1, SSB-12200-5
- Company Name
- ENTELLUS MEDICAL, INC.
- Labeler DUNS
- 017283879
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-25
- Public Version
- 2
- Public Version Date
- 2023-07-07
- Public Version Status
- Update
- Public Device Record Key
- ee4863f3-e81b-40f1-aa4b-32596ee82aa5
Device Description
Shaver Blade 2.1mm Single Use Double Serrated Straight
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
- No
- 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 |
|---|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | 874.4140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45003 | ENT suction dissector | A hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10857326005830 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00857326005833 | GS1 | ||||
| Package | 20857326005837 | GS1 | Box | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 25 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius