FDA UDI
In Commercial Distribution
🇺🇸 United States
mytaMed
DI: B351GC03800
·
Model: GC0380
·
Mytamed, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- mytaMed
- Primary DI
- B351GC03800
- Version / Model
- GC0380
- Catalog Number
- GC0380
- Company Name
- Mytamed, Inc.
- Labeler DUNS
- 015903922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-11
- Public Version
- 1
- Public Version Date
- 2021-02-19
- Public Version Status
- New
- Public Device Record Key
- 7b762afb-dc12-4544-857f-4bf01cc8eebf
Device Description
Shea Ear Speculum Holder, Complete
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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JYK | Holder, Ear Speculum | General, Plastic Surgery | 878.1800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33429 | ENT speculum holder | A device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands-free during a surgical intervention. The holder is typically fastened to the side rail of the operating table and can be adjusted to a desired position. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B351GC03800 | HIBCC |