FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
DI: 10888628002807
·
Model: FM-410180
·
Allergan, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants
- Primary DI
- 10888628002807
- Version / Model
- FM-410180
- Catalog Number
- FM-410180
- Company Name
- Allergan, Inc.
- Labeler DUNS
- 144796497
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2013-02-20
- Public Version
- 1
- Public Version Date
- 2021-12-10
- Public Version Status
- New
- Public Device Record Key
- d0e9c6e4-7089-496b-a312-56c395e08848
- Distribution End Date
- 2019-07-24
Device Description
STYLE 410, FM, 180G
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
- 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 |
|---|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | General, Plastic Surgery | 878.3540 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36197 | Silicone gel-filled breast implant | A sterile implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel. The implant 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 | 10888628002807 | GS1 |
Customer Contacts
- Phone
- 8006244261
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 180 cc |