FDA UDI
In Commercial Distribution
🇺🇸 United States
Clarity® Retractor System
DI: 00846468049393
·
Model: 38-STIM
·
Pioneer Surgical Technology, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Clarity® Retractor System
- Primary DI
- 00846468049393
- Version / Model
- 38-STIM
- Catalog Number
- 38-STIM
- Company Name
- Pioneer Surgical Technology, Inc.
- Labeler DUNS
- 793384496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-31
- Public Version
- 2
- Public Version Date
- 2021-10-14
- Public Version Status
- Update
- Public Device Record Key
- 4608abc3-f133-48b5-b0aa-92e2a829b6ae
Device Description
Nerve Monitoring Cable, Large
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 |
|---|---|---|---|---|
| GXZ | Electrode, Needle | Neurology | 882.1350 | 2 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36081 | Nerve-function monitor | A mains electricity (AC-powered) bedside device designed to continuously assess the adequacy of the nerve function of a non-ambulatory patient who requires monitoring (e.g., as a result of trauma, anaesthesia, intervention, evaluation). It typically monitors evoked potential (EP), electromyography (EMG), electroencephalography (EEG) and/or neuromuscular block response. It typically consists of electrodes applied to the patient intended to acquire the neural electrical signal, and a computerized unit to process and display the information; stimulation systems for nerve block and evoked potential evaluation are separate requirements. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846468049393 | GS1 |
Customer Contacts
- Phone
- 13864188888
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142438 | 000 |