FDA UDI
In Commercial Distribution
🇺🇸 United States
IDEAL IMPLANT
DI: 10851795006138
·
Model: 67501
·
IDEAL IMPLANT INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IDEAL IMPLANT
- Primary DI
- 10851795006138
- Version / Model
- 67501
- Catalog Number
- 675
- Company Name
- IDEAL IMPLANT INCORPORATED
- Labeler DUNS
- 005225418
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-09
- Public Version
- 4
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- ac011a68-fa10-41d0-8226-5ca861614b34
Device Description
Round, smooth-surface, saline-filled breast implant.
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | General, Plastic Surgery | 878.3530 | 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 | 10851795006138 | GS1 |
Customer Contacts
- Phone
- 214-492-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120011 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Total Volume, 675 cc |