AccessGUDID - DEVICE: Checkpoint Edge Nerve Cutting Kit (B13092500)

GUDID

Device Identifier (DI) Information

Brand Name: Checkpoint Edge Nerve Cutting Kit
Version or Model: 9250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9250
Company Name: Checkpoint Surgical, Inc.

Primary DI Number: B13092500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832575364 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	Instrument, Surgical, Non-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b4bf186e-15ce-4236-959a-2d12cefc9f66
Public Version Date: May 17, 2022
Public Version Number: 1
DI Record Publish Date: May 09, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B13092501	1	B13092500	In Commercial Distribution	pouch
B13092502	1	B13092501	In Commercial Distribution	box
B13092503	1	B13092502	In Commercial Distribution	shipping carton