FDA UDI
In Commercial Distribution
🇺🇸 United States
Millennium
DI: 00190776085100
·
Model: GL5350
·
Avalign Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Millennium
- Primary DI
- 00190776085100
- Version / Model
- GL5350
- Company Name
- Avalign Technologies, Inc.
- Labeler DUNS
- 792528510
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-22
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1973a4fb-ce2e-475f-a29d-7deb585327c5
Device Description
Elliot Obstetrical Forcep,
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| HDA | Forceps, obstetrical | Obstetrics/Gynecology | 884.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35082 | Obstetrical forceps, reusable | A scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. It typically is designed with two curved blades are that are introduced separately and then connected to a handle to exert traction on the foetal head or to rotate the foetal head in order to facilitate its passage through the birth canal. It is made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190776085100 | GS1 |
Customer Contacts
- Phone
- +1(877)289-1096
- [email protected]