FDA UDI
In Commercial Distribution
🇺🇸 United States
Surge Cardiovascular
DI: 00817278011351
·
Model: CAR-1613
·
Med Michigan Holdings, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Surge Cardiovascular
- Primary DI
- 00817278011351
- Version / Model
- CAR-1613
- Catalog Number
- CAR-1613
- Company Name
- Med Michigan Holdings, LLC
- Labeler DUNS
- 097462979
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 7
- Public Version Date
- 2022-09-21
- Public Version Status
- Update
- Public Device Record Key
- c73f4c7b-d3a8-4c13-b94f-b4d6137a6b33
Device Description
Coronary Artery Retraction Clip, 3.0mm, Non-Sterile
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47821 | Surgical retractor/retraction system blade, single-use | A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817278011355 | GS1 | Case | 4 | Not in Commercial Distribution | 2018-03-26 |
| Package | 10817278011358 | GS1 | Inner Bag | 25 | Not in Commercial Distribution | 2018-03-26 |
| Primary | 00817278011351 | GS1 | ||||
| Package | 00817278012501 | GS1 | Case | 100 | In Commercial Distribution |