FDA UDI
In Commercial Distribution
🇺🇸 United States
Motiva Implant Matrix
DI: 07445161014573
·
Model: SZD-320
·
Establishment Labs S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Motiva Implant Matrix
- Primary DI
- 07445161014573
- Version / Model
- SZD-320
- Catalog Number
- SZD-320
- Company Name
- Establishment Labs S.A.
- Labeler DUNS
- 853166098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-25
- Public Version
- 1
- Public Version Date
- 2021-11-02
- Public Version Status
- New
- Public Device Record Key
- a57aae2d-4650-4f99-921d-71cf2030a6cf
Device Description
Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Demi 320 cc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRD | Sizer, Mammary, Breast Implant Volume | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34178 | Invasive breast implant sizer, fixed, single-use | A device intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel, which is placed in the pocket and then removed. The sizer may vary in shape, profile, and volume. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07445161014573 | GS1 |