FDA UDI
In Commercial Distribution
🇺🇸 United States
SafeSharp Transseptal Needle
DI: 00858769006425
·
Model: CLICK071
·
PPMDM
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SafeSharp Transseptal Needle
- Primary DI
- 00858769006425
- Version / Model
- CLICK071
- Catalog Number
- CLICK071
- Company Name
- PPMDM
- Labeler DUNS
- 081047841
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-02
- Public Version
- 1
- Public Version Date
- 2024-07-10
- Public Version Status
- New
- Public Device Record Key
- 0c9b5a70-9572-4e76-850e-b2a17b0a0897
Device Description
71cm Sharp Needle Curve 0 in Five Unit Box
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
- Yes
- 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 |
|---|---|---|---|---|
| DRC | Trocar | Cardiovascular | 870.1390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47248 | Cardiac transseptal needle, single-use | A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30858769006426 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00858769006425 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241042 | 000 |