FDA UDI
In Commercial Distribution
🇺🇸 United States
TruDi Curette
DI: 20705031465432
·
Model: TDC0005Z
·
ACCLARENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TruDi Curette
- Primary DI
- 20705031465432
- Version / Model
- TDC0005Z
- Catalog Number
- TDC0005Z
- Company Name
- ACCLARENT, INC.
- Labeler DUNS
- 361092450
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 1
- Public Version Date
- 2020-09-08
- Public Version Status
- New
- Public Device Record Key
- 218691ad-86a3-477d-9b01-b623648ccb32
Device Description
TruDi Curette, 0°, 5IN - 1PK
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PGW | Ear, Nose, and Throat Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61478 | Surgical soft-tissue manipulation forceps, scissors-like, single-use | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20705031465432 | GS1 |
Customer Contacts
- Phone
- +1(650)687-5888
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201174 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.