FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniPore Surgical Implant Cutting Guide
DI: 00855421005987
·
Model: OP1002
·
MATRIX SURGICAL HOLDINGS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OmniPore Surgical Implant Cutting Guide
- Primary DI
- 00855421005987
- Version / Model
- OP1002
- Company Name
- MATRIX SURGICAL HOLDINGS, LLC
- Labeler DUNS
- 079634199
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-16
- Public Version
- 1
- Public Version Date
- 2020-04-24
- Public Version Status
- New
- Public Device Record Key
- d2b51eb0-1112-48f1-937b-78d919376791
Device Description
InvisiShunt Cutting Guide
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | General, Plastic Surgery | 878.3500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33310 | Polyethylene craniofacial tissue reconstructive material | A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855421005987 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123908 | 000 |