FDA UDI
In Commercial Distribution
🇺🇸 United States
Transitionless Radial Access Introducer
DI: 00841268108554
·
Model: CLI-134-55
·
GALT MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Transitionless Radial Access Introducer
- Primary DI
- 00841268108554
- Version / Model
- CLI-134-55
- Catalog Number
- CLI-134-55
- Company Name
- GALT MEDICAL CORP.
- Labeler DUNS
- 943156836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-28
- Public Version
- 2
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- 06f61837-24c7-4703-b841-c72bfc772fab
Device Description
Transitionless Radial Access Introducer
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36079 | Haemostasis valve | A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20841268108558 | GS1 | Shipper Box | 100 | In Commercial Distribution | |
| Package | 10841268108551 | GS1 | Shelf Box | 10 | In Commercial Distribution | |
| Primary | 00841268108554 | GS1 |
Customer Contacts
- Phone
- 800-639-2800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043525 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French |