FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro-Introducer Kit
DI: 00841268110380
·
Model: KIT-100-02
·
GALT MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Micro-Introducer Kit
- Primary DI
- 00841268110380
- Version / Model
- KIT-100-02
- Catalog Number
- KIT-100-02
- Company Name
- GALT MEDICAL CORP.
- Labeler DUNS
- 943156836
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-19
- Public Version
- 1
- Public Version Date
- 2026-01-27
- Public Version Status
- New
- Public Device Record Key
- dbdc6b9f-b0e9-4e62-b61f-51f158033091
Device Description
Micro-Introducer Kit
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| OFL | Percutaneous Sheath Introducer Kit | Cardiovascular | 870.1340 | 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 | 10841268110387 | GS1 | Shelf | 10 | In Commercial Distribution | |
| Primary | 00841268110380 | GS1 | ||||
| Package | 20841268110384 | GS1 | Shipper | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-639-2800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French |