TruDi Shaver Blade
- Primary DI
- 20705031469263
- Company
- ACCLARENT, INC.
- Model
- TSB440Z
- Catalog number
- TSB440Z
- Device description
- Trudi Shaver Blade 4.0mm - 40° Curved - 1pk
- Published
- 2022-09-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 361092450
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20705031469263 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 20705031469263 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 2 | Ear, Nose, Throat | 874.4250 | N | Ineligible |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K221037 | 000 | TruDi Shaver Blade | Acclarent, Inc. | 2022-07-20 | PGW |
GMDN Terms
| Term | Definition |
|---|
| Metal/carbide ENT bur, single-use | A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device. |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in a cool, dry place |
Contacts
| Phone | Email |
|---|
| +1(650)687-5888 | xx@xx.xx |
| +1(800)654-2873 | custsvcnj@integralife.com |
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