FDA UDI
In Commercial Distribution
🇺🇸 United States
JOSEPH LAMELAS Atrial Lift System
DI: 00858733006017
·
Model: 10.0
·
Biorep Technologies, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- JOSEPH LAMELAS Atrial Lift System
- Primary DI
- 00858733006017
- Version / Model
- 10.0
- Catalog Number
- MI-ALS-001
- Company Name
- Biorep Technologies, Inc.
- Labeler DUNS
- 073724333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-23
- Public Version
- 1
- Public Version Date
- 2024-05-01
- Public Version Status
- New
- Public Device Record Key
- 4e693e2b-2be3-4edb-a895-05b8286466e8
Device Description
The JOSEPH LAMELAS Atrial Lift System device is a set of 4 disposable surgical instrument components packaged together as a system for use as a single surgical instrument for atrial wall tissue retraction.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57992 | Atrial retractor | A sterile, self-expanding, manual surgical device designed to separate the edges of a left atrium wall incision (atriotomy) so that the mitral valve can be easily accessed during surgery. The device is typically made of a flat polymeric sheet that is bent by the surgeon to form a conical cylinder; the opposing ends are locked together with a sliding mechanism that allows the device to be held together with forceps or a clamp as a compressed cylinder for introduction to the site where it expands once in situ. It is available in a variety of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10858733006014 | GS1 | Shelf Box | 6 | In Commercial Distribution | |
| Primary | 00858733006017 | GS1 |