FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00852073002524
·
Model: Uterine Injector, 4.0
·
C R I
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00852073002524
- Version / Model
- Uterine Injector, 4.0
- Catalog Number
- TMI1152
- Company Name
- C R I
- Labeler DUNS
- 130814890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-10
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 18ebf60e-aab0-43de-a051-d3d9cf3a8e21
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
- 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 |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34157 | Salpingographic catheter | A flexible, balloon-tipped tube inserted transvaginally and through the uterus for the selective catheterization/cannulation of the fallopian tubes, in order to inject dye or a contrast medium into the tubes for a radiographic procedure; it is usually radiopaque. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10852073002521 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00852073002524 | GS1 |
Customer Contacts
- Phone
- (800) 556-0349
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020292 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4 | Millimeter | |
| Length | 23 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight