FDA UDI
In Commercial Distribution
🇺🇸 United States
Ranfac Filter Assembly
DI: 00858690006303
·
Model: RAN-FILTER
·
RANFAC CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ranfac Filter Assembly
- Primary DI
- 00858690006303
- Version / Model
- RAN-FILTER
- Catalog Number
- RAN-FILTER
- Company Name
- RANFAC CORP.
- Labeler DUNS
- 121622872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-12
- Public Version
- 1
- Public Version Date
- 2019-04-22
- Public Version Status
- New
- Public Device Record Key
- d925346b-8108-4963-9cc5-56390fb82d5f
Device Description
Ranfac Filter Assembly, F/G, Sterile PN 76080-01M
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
- 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 |
|---|---|---|---|---|
| KET | Filters, Cell Collection, Tissue Processing | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47624 | Bone graft harvesting filter | A sterile receptacle designed to collect morselized (cut/shredded into small pieces) bone and bone marrow typically obtained during an intramedullary procedure involving reaming, irrigation, and aspiration (suction). The filter is situated, with connection tubing, between the bone harvesting device (e.g., the orthopaedic reamer handpiece) and a suction system which creates vacuum to draw the graft into the filter where it is captured. The retrieved tissue is used for surgical procedures requiring bone graft (e.g., to facilitate bone fusion and/or fill bone defects). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10858690006300 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00858690006303 | GS1 |
Customer Contacts
- Phone
- 5085884400
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pore Size | 150 | Micrometer |