FDA UDI
In Commercial Distribution
🇺🇸 United States
Ezy Dose
DI: 00079573109281
·
Model: 400928/400928A
·
APOTHECARY PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Ezy Dose
- Primary DI
- 00079573109281
- Version / Model
- 400928/400928A
- Company Name
- APOTHECARY PRODUCTS, LLC
- Labeler DUNS
- 092312735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-16
- Public Version
- 2
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- 7ce8bcdc-b0b5-4154-8729-6ab73cd09e4b
Device Description
OTO SCOOP BLS
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JZE | Spoon, Ear | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47522 | Endaural surgical curette, reusable | A slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10079573109288 | GS1 | inner | 6 | In Commercial Distribution | |
| Primary | 00079573109281 | GS1 | ||||
| Package | 20079573109285 | GS1 | case | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- 952-890-1940
- [email protected]