FDA UDI
In Commercial Distribution
🇺🇸 United States
American Hospital Supply
DI: 00850037921973
·
Model: AHSEC77_CS
·
American Hospital Supply LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
750
Basic Information
- Brand Name
- American Hospital Supply
- Primary DI
- 00850037921973
- Version / Model
- AHSEC77_CS
- Catalog Number
- AHSEC77_CS
- Company Name
- American Hospital Supply LLC
- Labeler DUNS
- 118098262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 750
- Record Status
- Published
- Publish Date
- 2023-02-17
- Public Version
- 1
- Public Version Date
- 2023-02-27
- Public Version Status
- New
- Public Device Record Key
- 4f178acd-5e25-4873-a2c5-e04d678bebbf
Device Description
American Hospital Supply (AHS) Disposable Ear Curette | Ear Wax Removal Tool Variety Tip Pack | Case of 750
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 | 00850046814532 | GS1 | ||||
| Primary | 00850037921973 | GS1 |
Customer Contacts
- Phone
- 888-621-5011
- [email protected]