FDA UDI
In Commercial Distribution
🇺🇸 United States
American Medicals
DI: B35641299030
·
Model: 1
·
American Medicals
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- American Medicals
- Primary DI
- B35641299030
- Version / Model
- 1
- Company Name
- American Medicals
- Labeler DUNS
- 109909627
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-14
- Public Version
- 1
- Public Version Date
- 2022-09-22
- Public Version Status
- New
- Public Device Record Key
- 645aa6c4-7ed6-4d2d-a6d4-e88c90cb01cb
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Microwave Radiation
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JZF | Tube, Ear Suction | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65234 | Ear canal material application syringe/cannula | A device consisting of a barrel (cylinder) with plunger and a permanently attached blunt cannula intended for the application of a liquid/semi-liquid material/pharmaceutical (e.g., corticosteroid or antibiotic cream, local anaesthetic agent) into the external auditory canal, as part of a treatment or during a procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B35641299030 | HIBCC |