FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPSY FORCEPS STD
DI: 10705032056120
·
Model: 504302L
·
Cordis US Corp.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BIOPSY FORCEPS STD
- Primary DI
- 10705032056120
- Version / Model
- 504302L
- Catalog Number
- 504302L
- Company Name
- Cordis US Corp.
- Labeler DUNS
- 118274128
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-23
- Public Version
- 2
- Public Version Date
- 2025-09-05
- Public Version Status
- Update
- Public Device Record Key
- 96d61a9e-8316-4467-b406-cf0e8f9a02c8
Device Description
BIOPSY FORCEPS 7F 50CM
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
- 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 |
|---|---|---|---|---|
| DWZ | DEVICE, BIOPSY, ENDOMYOCARDIAL | Cardiovascular | 870.4075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46679 | Endomyocardial biopsy forceps, single-use | A sterile grasping instrument designed to obtain tissue samples from the inner walls of the heart (endomyocardium) typically for histopathological examination. It is typically a flexible metal coil or plastic tube with a pair of scissors-like cups with cutting edges around their rims at the distal end which are operated by a handle attached at the proximal end. It is usually introduced percutaneously through the jugular vein or femoral artery (during catheterization). Acquired tissue samples are typically used for assessment of early rejection of a transplanted heart, cardiomyopathy and myocarditis diagnosis, or detection of antracycline cardiotoxicity. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20705032056127 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 10705032056120 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K810849 | 000 |