FDA UDI
In Commercial Distribution
🇺🇸 United States
Diaphragm Valve Fill Tube and Reflux Valve
DI: 10888628006287
·
Model: 25-00017
·
Allergan, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diaphragm Valve Fill Tube and Reflux Valve
- Primary DI
- 10888628006287
- Version / Model
- 25-00017
- Catalog Number
- 25-00017
- Company Name
- Allergan, Inc.
- Labeler DUNS
- 144796497
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-19
- Public Version
- 3
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- a77689ee-9968-4e07-b068-228b54e4365d
Device Description
Diaphragm Valve Fill Tube & Reflux Valve
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | General, Plastic Surgery | 878.3540 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36196 | Saline-filled breast implant, unstructured | A sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber outer shell, made of polysiloxane(s), with a single lumen inflated with sterile isotonic saline to the desired size. The implant may be of fixed or adjustable volume and may be prefilled, partially filled, or empty and filled during the implantation procedure; the volume of saline solution in adjustable volume implants may be adjusted after implantation. The device may vary in shape, profile, volume, shell surface, and shell thickness. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888628006287 | GS1 |
Customer Contacts
- Phone
- 8006244261
- [email protected]