FDA UDI
In Commercial Distribution
🇺🇸 United States
PREFERX DELIVERY SYSTEM, DISPOSABLE
DI: B992151000
·
Model: 15-100
·
JB Medical Development, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PREFERX DELIVERY SYSTEM, DISPOSABLE
- Primary DI
- B992151000
- Version / Model
- 15-100
- Catalog Number
- 15100
- Company Name
- JB Medical Development, LLC
- Labeler DUNS
- 873149871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-29
- Public Version
- 2
- Public Version Date
- 2026-03-20
- Public Version Status
- Update
- Public Device Record Key
- 10393e6e-db7a-461c-9b05-dfaeb259c052
Device Description
THE PREFERX DELIVERY SYSTEM IS INTENDED TO BE USED FOR THE DELIVERY OF HYDRATED ALLOGRAFT, AUTOGRAFT, OR SYNTHETIC BONE GRAFT MATERIAL TO AN ORTHOPEDIC SURGICAL SITE.
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
- No
- 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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35809 | Orthopaedic cement dispenser | A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B992151000 | HIBCC |
Customer Contacts
- Phone
- 18776036333
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210997 | 000 |