FDA UDI
In Commercial Distribution
🇺🇸 United States
Digital MurphyScope Endoscope
DI: 00810004821118
·
Model: 2125-515
·
CLARUS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Digital MurphyScope Endoscope
- Primary DI
- 00810004821118
- Version / Model
- 2125-515
- Catalog Number
- 2125-515
- Company Name
- CLARUS MEDICAL, LLC
- Labeler DUNS
- 010316284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-21
- Public Version
- 1
- Public Version Date
- 2026-04-29
- Public Version Status
- New
- Public Device Record Key
- 614a467a-6932-40e0-a347-423a5cbfbee9
Device Description
Digital MurphyScope Endoscope
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 |
|---|---|---|---|---|
| GWG | Endoscope, Neurological | Neurology | 882.1480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63425 | Rigid video intracranial/spinal endoscope | An endoscope with a rigid distal portion intended for the visual examination and treatment of the brain (e.g., ventricles, hydrocephalus) and/or spine and contents [e.g., vertebrae, intervertebral discs, spinal cord (myeloscopy)]; it is not dedicated for use in the epidural space (i.e., not a dedicated epiduroscope). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810004821118 | GS1 |
Customer Contacts
- Phone
- 763-525-8400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223615 | 000 |