AccessGUDID - DEVICE: CANNULATED PEDIGUARD (03662674000129)

GUDID

Device Identifier (DI) Information

Brand Name: CANNULATED PEDIGUARD
Version or Model: CANNULATED PEDIGUARD NEEDLE TROCAR 120mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P2ND1101
Company Name: SPINEGUARD

Primary DI Number: 03662674000129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 260589566 *Terms of Use

Device Description: No description.

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":	No
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?
15275	Bone awl, reusable	A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ETN	Stimulator, Nerve
PDQ	Neurosurgical Nerve Locator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143159	000

Device Exempt from Premarket Submission: No 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 -5 and 30 Degrees Celsius
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Handling Environment Humidity: less than 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 120 Millimeter
Outer Diameter: 3.0 Millimeter

Device Record Status

Public Device Record Key: 97e02db1-e52a-4d9f-a59c-966ed11c966b
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: August 29, 2016