FDA UDI
In Commercial Distribution
🇺🇸 United States
Guardian Probe Extension Ball Tip, 12 cm
DI: B13095050
·
Model: 9505
·
Checkpoint Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Guardian Probe Extension Ball Tip, 12 cm
- Primary DI
- B13095050
- Version / Model
- 9505
- Catalog Number
- 9505
- Company Name
- Checkpoint Surgical, Inc.
- Labeler DUNS
- 832575364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-02
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- c12f1da7-0951-474b-b5d4-863dd6efa29c
Device Description
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
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 |
|---|---|---|---|---|
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35723 | Nerve-locating system | An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing observed muscle responses with the expected maximum contractions. The system includes an electrical pulse generator, appropriate electrodes, sensors to detect muscle response (e.g., a strain gauge), and audible and/or visual indicators it does not display electromyography (EMG) readings. It is used during the diagnosis and assessment of nerve function and to locate nerves during surgery to reduce the incidence of accidental injury. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B13095051 | HIBCC | pouch | 1 | In Commercial Distribution | |
| Primary | B13095050 | HIBCC | ||||
| Package | B13095052 | HIBCC | sales carton | 1 | In Commercial Distribution | |
| Package | B13095053 | HIBCC | shipping box | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 2163789107
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092292 | 000 |