EDGe Surgical, Inc
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000052496
- Devices
- 4
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
Catalogue
EDG Ortho 65mm (pack of 10) Ref 21342-65-10-10-LN
CE MDD EUDAMED- GUDID
- CE MDR CE MDD EUDAMEDGUDID
- GUDID
Company details
- EUDAMED SRN
- US-MF-000052496
- DUNS number
- 080787313
- EUDAMED status
- Active
- EUDAMED registered name
- EDGe Surgical, Inc
- EUDAMED abbreviated name
- EDGe
- Registered address
- 10, Burlington Mall Road, 01803, Massachusets, United States
- Website
- www.edgesurgical.com
- [email protected]
- Phone
- 17813450066
- PRRC contact
- Christopher Wilson
FDA establishments
- Edge Surgical, Inc. Burlington, MA · US FEI 3014282569
From the company website
The EDG® by EDGE Surgical is the world's only sterile, universal, and digital Depth Gauge. In use at leading hospitals, EDG saves time, money and reduces risk in orthopedic surgery.
Frequently asked questions
How many devices does EDGe Surgical, Inc have in the registry?
The registry currently lists 4 devices for EDGe Surgical, Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list EDGe Surgical, Inc's devices?
Among its 4 most recently registered devices, EDGe Surgical, Inc has devices listed in EUDAMED (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do EDGe Surgical, Inc's devices fall under?
Among its 4 most recently registered devices, the classes recorded for EDGe Surgical, Inc's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from EDGe Surgical, Inc in the registry?
The most recently registered devices listed for EDGe Surgical, Inc include EDG Ortho 65mm (pack of 10), EDG® Ortho 65mm 21342-65-01-40-LN, EDG® Ortho 65mm 21342-65-01-10-LN and EDG® Ortho 65mm 21342-65-01.
Which FDA establishments are linked to EDGe Surgical, Inc?
1 FDA establishment is linked to EDGe Surgical, Inc in the registry; they are listed on the company page.