FDA UDI
In Commercial Distribution
🇺🇸 United States
GALACTOGRAPHY STRAIGHT INFUSION, 31 GA
DI: M9796800807M0
·
Model: 31 Gauge
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- GALACTOGRAPHY STRAIGHT INFUSION, 31 GA
- Primary DI
- M9796800807M0
- Version / Model
- 31 Gauge
- Catalog Number
- 31G-END
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 68d95b2f-bb6a-4339-b23b-2e077d1c70ce
Device Description
GALACTOGRAPHY STRAIGHT INFUSION, 31 GA, 31G-END PN68008-07M
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
- 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 |
|---|---|---|---|---|
| GCB | Needle, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46669 | Breast ductography cannula | A thin, sterile, semi-rigid or rigid metal tube that is inserted into the nipple of the female breast to inject a contrast medium into the lactiferous ducts to enhance their visualization during a radiographic procedure. It is typically made of high-grade stainless steel and is designed with a blunt distal tip; it has a connector at the proximal end for attachment to a device that propels the contrast medium. This metal tube is typically used to help define the cause of nipple discharge from intraductal abnormalities such as neoplasms, ductal ectasia, or fibrocystic changes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M9796800807M9 | HIBCC | Case | 22 | In Commercial Distribution | |
| Package | M9796800807M1 | HIBCC | Inner Pack | 10 | In Commercial Distribution | |
| Primary | M9796800807M0 | HIBCC |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 31 | Gauge |