FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SPiN Access Catheter Adapter, Olympus 190
DI: 00815686021245
·
Model: INS-5902
·
VERAN MEDICAL TECHNOLOGIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SPiN Access Catheter Adapter, Olympus 190
- Primary DI
- 00815686021245
- Version / Model
- INS-5902
- Catalog Number
- INS-5902
- Company Name
- VERAN MEDICAL TECHNOLOGIES INC.
- Labeler DUNS
- 181714804
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-30
- Public Version
- 4
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 3ff425fb-2b0b-4d00-aa1d-09fd6b5d72e8
- Distribution End Date
- 2023-08-10
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57786 | Bronchoscopic catheter | A sterile, flexible, single lumen tube designed to be used as a conduit to the lung(s) for the delivery of another device (e.g., an emphysematous lung sealant) during a bronchoscopic procedure. It is typically made of synthetic materials that resist kinking (may be capable of bending 135 degrees or more without kinking) and is advanced through the working channel of a bronchoscope to the treatment site by the operator, typically a pulmonologist or thoracic surgeon. The distal tip may be marked with a band to facilitate visualization by the operator during the procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815686021245 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170023 | 000 |