FDA UDI
In Commercial Distribution
🇺🇸 United States
American Medicals
DI: B35670500000
·
Model: 1
·
American Medicals
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- American Medicals
- Primary DI
- B35670500000
- 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
- 2022-09-07
- Public Version
- 2
- Public Version Date
- 2023-01-20
- Public Version Status
- Update
- Public Device Record Key
- 2aae4770-229e-457c-bfb2-ed0f5857f34c
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 |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63993 | Uterine probe | A slender, rod-like, hand-held manual surgical instrument intended to be used to explore the uterus during a surgical procedure. It is typically intended to be used as a component of a uterine manipulator and as such may have a suction channel for applying a vacuum to fixate the manipulator assembly to the uterus. It is made of metal with an atraumatic tip; it may include graduated markings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B35670500000 | HIBCC |