FDA UDI
Not in Commercial Distribution
🇺🇸 United States
.018"(0.46MM) X 35CM ALLEVIO GUIDEWIRE
DI: 00810988020811
·
Model: JT110183500
·
JET MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- .018"(0.46MM) X 35CM ALLEVIO GUIDEWIRE
- Primary DI
- 00810988020811
- Version / Model
- JT110183500
- Catalog Number
- JT110183500
- Company Name
- JET MEDICAL, INC.
- Labeler DUNS
- 079506014
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-20
- Public Version
- 4
- Public Version Date
- 2019-05-03
- Public Version Status
- Update
- Public Device Record Key
- 5ca835af-91c1-4684-aa37-f1e9cfb9eb0f
- Distribution End Date
- 2019-04-22
Device Description
.018" (0.46MM) X 35CM ALLEVIO GUIDEWIRE
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
- 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 |
|---|---|---|---|---|
| KCJ | Applicator, Ent | Ear, Nose, Throat | 874.5220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16432 | Nasopharyngeal catheter | A flexible tube intended to be used to access the nasopharyngeal cavity for suction or delivery of medication. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50810988020816 | GS1 | 5 | Not in Commercial Distribution | 2019-04-22 | |
| Primary | 00810988020811 | GS1 |
Customer Contacts
- Phone
- 18663854047
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Centimeter | |
| Outer Diameter | .46 | Millimeter | |
| Outer Diameter | .018 | Inch |