FDA UDI
In Commercial Distribution
🇺🇸 United States
Checkpoint Edge Nerve Cutting Kit
DI: B13092500
·
Model: 9250
·
Checkpoint Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Checkpoint Edge Nerve Cutting Kit
- Primary DI
- B13092500
- Version / Model
- 9250
- Catalog Number
- 9250
- Company Name
- Checkpoint Surgical, Inc.
- Labeler DUNS
- 832575364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-09
- Public Version
- 1
- Public Version Date
- 2022-05-17
- Public Version Status
- New
- Public Device Record Key
- b4bf186e-15ce-4236-959a-2d12cefc9f66
Device Description
The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to provide surgeon aid in transecting nerve tissue for the purpose of nerve graft preparation, nerve repair, or removal of exposed nerve. The kit includes three circumferential nerve constraining forceps, two blades, and a silicone visibility background.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62479 | Surgical soft-tissue manipulation forceps, tweezers-like, single-use | A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B13092501 | HIBCC | pouch | 1 | In Commercial Distribution | |
| Primary | B13092500 | HIBCC | ||||
| Package | B13092502 | HIBCC | box | 1 | In Commercial Distribution | |
| Package | B13092503 | HIBCC | shipping carton | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 2163789107
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius