FDA UDI
In Commercial Distribution
🇺🇸 United States
Primum Guiding Catheter
DI: 08718122028896
·
Model: 6F Primum EBU3.5
·
PendraCare International B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Primum Guiding Catheter
- Primary DI
- 08718122028896
- Version / Model
- 6F Primum EBU3.5
- Catalog Number
- 26108804
- Company Name
- PendraCare International B.V.
- Labeler DUNS
- 413008652
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-02
- Public Version
- 1
- Public Version Date
- 2026-02-10
- Public Version Status
- New
- Public Device Record Key
- 09117e9b-cb57-4dee-9ce0-1a79670c8d2a
Device Description
The Hydrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of intravascualar devices. Also available with two (2) Side Holes in the tip section.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38718122028897 | GS1 | box | 1 | In Commercial Distribution | |
| Primary | 08718122028896 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250972 | 000 |