FDA UDI
In Commercial Distribution
🇺🇸 United States
Clarus Flexible Fiberoptic Endoscope
DI: B0673000C0
·
Model: 3000C
·
CLARUS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Clarus Flexible Fiberoptic Endoscope
- Primary DI
- B0673000C0
- Version / Model
- 3000C
- Catalog Number
- 3000C
- Company Name
- CLARUS MEDICAL, LLC
- Labeler DUNS
- 010316284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 16aa7c89-2f21-4ebf-bd5f-6a6cf59a18db
Device Description
Endoscope, Flexible Fiberoptic
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
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical, Peracetic Acid, Hydrogen Peroxide, Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWG | Endoscope, Neurological | Neurology | 882.1480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45090 | Flexible fibreoptic epiduroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of intractable back and leg pain (e.g., chronic lumbago or sciatica). It is inserted into the body percutaneously through the sacral hiatus during epiduroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to facilitate and/or perform perfusion or wash in the epidural space, dissect epidural adhesions, or deliver medications. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B0673000C0 | HIBCC |
Customer Contacts
- Phone
- 763-525-8400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942249 | 000 |