Natrelle 133S Tissue Expanders
- Primary DI
- 10888628044210
- Brand
- Natrelle 133S Tissue Expanders
- Company
- Allergan, Inc.
- Model
- 133S-MX-15-T
- Catalog number
- 133S-MX-15-T
- Device description
- Natrelle TE Smooth 133S-MX-15-T (US)
- Published
- 2019-03-13
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| LCJ | Expander, Skin, Inflatable |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LCJ | Tissue Expander And Accessories | Unknown | U |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10888628044210 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10888628044210 | 10888628044210 |
GMDN Terms
| Term | Definition |
|---|
| Skin-port tissue expander | An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Regulatory Flags
- DUNS number
- 144796497
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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