FDA UDI
In Commercial Distribution
🇺🇸 United States
PeekMed
DI: 05600120304801
·
Model: v2
·
PEEK HEALTH, S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PeekMed
- Primary DI
- 05600120304801
- Version / Model
- v2
- Company Name
- PEEK HEALTH, S.A.
- Labeler DUNS
- 338110102
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-20
- Public Version
- 1
- Public Version Date
- 2025-03-28
- Public Version Status
- New
- Public Device Record Key
- 04ef5d20-79ca-41d4-a464-599e558c4316
Device Description
PeekMed is a system that allows healthcare professionals to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments. In the case of a 3D or hybrid environment, the healthcare professional can resort to a 3D model generated from a previous imaging study on the patient and 3D digital representations of the implant material to be used during surgery, i.e. screws, fixation plates, or full prosthesis, deriving from several producing companies. Being software it does not interact with any part of the body of the user and/or patient.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46470 | Orthopaedic/craniofacial implantation planning software | A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05600120304801 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182464 | 000 |