FDA UDI
In Commercial Distribution
🇺🇸 United States
Xpression Box
DI: D742CTR0
·
Model: CTR
·
INTRA-LOCK INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Xpression Box
- Primary DI
- D742CTR0
- Version / Model
- CTR
- Catalog Number
- CTR
- Company Name
- INTRA-LOCK INTERNATIONAL, INC.
- Labeler DUNS
- 131500998
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-08
- Public Version
- 3
- Public Version Date
- 2020-08-31
- Public Version Status
- Update
- Public Device Record Key
- 017ce77c-92e8-4018-a63f-1df10f1c8296
Device Description
Xpression Box
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKF | Instrument, Contouring, Matrix, Operative | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47183 | Haematological concentrate system | An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D742CTR0 | HIBCC |
Customer Contacts
- Phone
- 877-330-0338
- [email protected]