FDA UDI
In Commercial Distribution
🇺🇸 United States
Intra-Art Coronary Artery Retraction Clip
DI: B040CRC51
·
Model: CRC-5
·
GENESEE BIOMEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Intra-Art Coronary Artery Retraction Clip
- Primary DI
- B040CRC51
- Version / Model
- CRC-5
- Company Name
- GENESEE BIOMEDICAL, INC.
- Labeler DUNS
- 939872651
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f3edbd45-b216-4168-9029-0e751fe96067
Device Description
Coronary Artery Retraction Clip
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62493 | Coronary artery exposure retractor | A sterile, tensionable, surgical instrument designed to be used during cardiac bypass graft anastomosis surgery to provide hands-free (self-retaining) retraction of the fatty surface layer over the myocardium adjacent to the coronary artery, to facilitate exposure of the artery. It is made of stainless steel and is in the form of a clip with leg/prong extensions that uses mechanical spring tension to maintain exposed tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B040CRC52 | HIBCC | 1 | In Commercial Distribution | ||
| Primary | B040CRC51 | HIBCC |
Customer Contacts
- Phone
- 800 786-4890
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K882981 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Millimeter |