FDA UDI
In Commercial Distribution
🇺🇸 United States
Catapult Guide Sheath
DI: 04251244502775
·
Model: 5F, 130cm, Straight, hydrophilic coated
·
Contract Medical International GmbH
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Catapult Guide Sheath
- Primary DI
- 04251244502775
- Version / Model
- 5F, 130cm, Straight, hydrophilic coated
- Catalog Number
- US-35130-F-ST-H
- Company Name
- Contract Medical International GmbH
- Labeler DUNS
- 330926895
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-19
- Public Version
- 1
- Public Version Date
- 2024-08-27
- Public Version Status
- New
- Public Device Record Key
- 77062949-ce0f-42fa-a995-e1794a86b56d
Device Description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. Introducer Sheath is hydrophilic coated on the distal end.
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
- 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 |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | 870.1310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14251244502772 | GS1 | Packer | 5 | In Commercial Distribution | |
| Primary | 04251244502775 | GS1 | ||||
| Package | 24251244502779 | GS1 | Corrugate | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +493512138888
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 130 | Centimeter | |
| Catheter Inner Diameter | 1.92 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Specify: Keep dry, Keep away from direct sunlight