FDA UDI
In Commercial Distribution
🇺🇸 United States
RAN-1115H2S C#0002262
DI: M979G65X0
·
Model: 11 Gauge X 15.24CM
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- RAN-1115H2S C#0002262
- Primary DI
- M979G65X0
- Version / Model
- 11 Gauge X 15.24CM
- Catalog Number
- G65X
- 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
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8046978d-b508-4a47-9c36-6d7fe4763902
Device Description
RAN-1115H2S C#0002262 PN 74290-01M
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 |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60478 | Bone access cannula | A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M979G65X9 | HIBCC | Case | 30 | In Commercial Distribution | |
| Package | M979G65X1 | HIBCC | Inner Pack | 1 | In Commercial Distribution | |
| Primary | M979G65X0 | HIBCC |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131157 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 11 | Gauge | |
| Length | 15.24 | Centimeter |