FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00852073002609
·
Model: HSG Tray
·
C R I
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00852073002609
- Version / Model
- HSG Tray
- Catalog Number
- TMI1160
- 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
- 39157022-c876-4224-aa30-7b227f4c9710
Device Description
Includes 5F HS Catheter
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
- 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 |
|---|---|---|---|---|
| 60880 | Intrauterine imaging medium catheterization kit | A collection of sterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It includes an intrauterine imaging medium catheter, devices dedicated to catheter function (e.g., stylet, syringe), and non-dedicated supportive devices (e.g., drape, cervical dialator, gauze pad, swab sticks). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10852073002606 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00852073002609 | GS1 |
Customer Contacts
- Phone
- (800) 556-0349
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032835 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 5 | French |