FDA UDI
In Commercial Distribution
🇺🇸 United States
Celt ACD Vascular Closure Device 6F_ESP
DI: 05391530280099
·
Model: KCLT-06
·
VASORUM LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Celt ACD Vascular Closure Device 6F_ESP
- Primary DI
- 05391530280099
- Version / Model
- KCLT-06
- Company Name
- VASORUM LIMITED
- Labeler DUNS
- 896197592
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-21
- Public Version
- 4
- Public Version Date
- 2020-10-21
- Public Version Status
- Update
- Public Device Record Key
- 51de286e-8ab7-44d6-b50b-108c2494644e
Device Description
Celt ACD Vascular Closure Device 6F_ESP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63225 | Implantable vascular closure clip | A non-bioabsorbable metallic clip intended to be implanted following a percutaneous catheterization procedure to close the punctured access site on an artery (typically femoral) and improve haemostasis. It is typically a small circular clip with grasping blades intended to close inwardly upon deployment; dedicated disposable devices (e.g., applicator) intended for implantation may be included with the device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391530280099 | GS1 | ||||
| Package | 05391530280105 | GS1 | Inner Carton | 5 | In Commercial Distribution | |
| Package | 05391530280112 | GS1 | Shipper Carton | 4 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150006 | 001 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Keep out of direct sunlight.