FDA UDI
In Commercial Distribution
🇺🇸 United States
Adult Curved Sternal Latch Retractor with Curved Atrial and Aortic Rakes
DI: B040SRCLARC0
·
Model: SRCL-ARC
·
GENESEE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Adult Curved Sternal Latch Retractor with Curved Atrial and Aortic Rakes
- Primary DI
- B040SRCLARC0
- Version / Model
- SRCL-ARC
- Catalog Number
- SRCL-ARC
- Company Name
- GENESEE BIOMEDICAL, INC.
- Labeler DUNS
- 939872651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-28
- Public Version
- 1
- Public Version Date
- 2024-09-05
- Public Version Status
- New
- Public Device Record Key
- 44bce767-8879-4def-9052-6033fce136d2
Device Description
Curved Sternal Latch Retractor with 2 sets of Blades and Curved Atrial and Aortic Rakes: Suitable for adult patients weighing from 45 to 90 kg
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GAD | Retractor | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46771 | Sternum spreader | A self-locking surgical instrument designed to force apart the surgically-split sternum (the breastbone) to permit surgical cardiac intervention within the thoracic cavity. This device will typically have two interchangeable profiled, pivoted blades (self-adjusting their angle as the instrument is opened) at the distal end that hook over the margins of the severed sternum, and a ratchet mechanism along its horizontal bar to adjust the blades, parting the sternum and maintain its set position once it has been set. It is also known as a sternum retractor and is available in various designs and sizes. It is made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B040SRCLARC0 | HIBCC |
Customer Contacts
- Phone
- 800-786-4980
- [email protected]