FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 20193489141501
·
Model: MDS202202
·
MEDLINE INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- Medline
- Primary DI
- 20193489141501
- Version / Model
- MDS202202
- Catalog Number
- MDS202202
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2023-12-18
- Public Version
- 1
- Public Version Date
- 2023-12-26
- Public Version Status
- New
- Public Device Record Key
- 5781a6ba-9c25-4bb5-802e-40bd9ef4d63d
Device Description
CURETTE,EAR,LIGHTED,3MM CIRC LOOP,CLINIC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JYG | CURETTE, EAR | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65445 | Endaural wax extraction curette | A hand-held, manual, non-surgical device intended to scrape within the ear canal primarily for the extraction of ear wax during an ear/nose/throat (ENT) procedure; it is not intended for surgical scraping or manipulation of tissues. It may have various designs (e.g., serrated or blunt loop, hook, straight or curved), and may include a magnifying lens and/or light source. 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 | 10193489141504 | GS1 | ||||
| Primary | 20193489141501 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]