FDA UDI
In Commercial Distribution
🇺🇸 United States
FeatherTouch®
DI: 20681490051525
·
Model: 1992208
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- FeatherTouch®
- Primary DI
- 20681490051525
- Version / Model
- 1992208
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-04-17
- Public Version
- 5
- Public Version Date
- 2021-03-05
- Public Version Status
- Update
- Public Device Record Key
- 20c77688-770f-472e-8ee7-940f24c94793
Device Description
RASP 1992208 FEATHERTOUCH 2PK COARSE
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRX | ARTHROSCOPE | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35296 | Nasal file/rasp | A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20681490051525 | GS1 | ||||
| Unit of Use | 00681490051521 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983025 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 8.0 | Millimeter |