FDA UDI
In Commercial Distribution
🇺🇸 United States
ASSI
DI: 00841645125587
·
Model: ASSI.AB22826
·
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ASSI
- Primary DI
- 00841645125587
- Version / Model
- ASSI.AB22826
- Company Name
- ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
- Labeler DUNS
- 055870299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-08
- Public Version
- 1
- Public Version Date
- 2020-07-16
- Public Version Status
- New
- Public Device Record Key
- 2510e17e-faae-4cda-922a-b12a58896dc1
Device Description
Lalonde Breast Sizer 1X, Size 5, 750cc Patent Pend.
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46179 | Noninvasive breast implant sizer | A clinical instrument typically used by a surgeon during breast reconstruction surgery consultation and/or preoperative planning as a guide to select an appropriately-sized breast implant (mammary prosthesis) and tissue expander. It is typically a transparent anatomical template used with other devices (e.g., calliper, measuring tape) to measure various dimensions of the patient's existing breast (e.g., width, height, projection) for selection of the optimal expander/prosthesis to achieve symmetry with reconstruction. The device is provided in a range of dimensions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841645125587 | GS1 |