FDA UDI
In Commercial Distribution
🇺🇸 United States
SIALOGRAPHY UNIT ENDPORT, 30GA
DI: M9796800803M0
·
Model: 30 Gauge
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SIALOGRAPHY UNIT ENDPORT, 30GA
- Primary DI
- M9796800803M0
- Version / Model
- 30 Gauge
- Catalog Number
- 30G-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
- b727e2aa-0ac1-40bb-bcd3-d6452da3676a
Device Description
SIALOGRAPHY UNIT ENDPORT, 30GA 30G-END PN 68008-03M
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 |
|---|---|---|---|---|
| 46451 | Salivary gland catheter | A sterile, thin flexible tube intended to be used to access the salivary glands typically to introduce a contrast medium to enhance the radiographic images of the glands during sialography. It is typically made of metal or plastic materials [e.g., polyethylene (PE), polyurethane] and will have a short length of rigid or flexible cannula extending from its distal end. This device may also be used for intraoperative cholangiography. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M9796800803M9 | HIBCC | Case | 22 | In Commercial Distribution | |
| Package | M9796800803M1 | HIBCC | Inner Pack | 10 | In Commercial Distribution | |
| Primary | M9796800803M0 | HIBCC |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 30 | Gauge |