AccessGUDID - DEVICE: COLORADO (04546540004123)

GUDID

Device Identifier (DI) Information

Brand Name: COLORADO
Version or Model: N104B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N104B
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540004123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: MicroDissection Needle straight sleeve

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Open-surgery electrosurgical electrode, monopolar, single-use	A sterile, invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Open-surgery electrosurgical electrode, monopolar, single-use

A sterile, invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 4.0 Centimeter
Device Size Text, specify: Diameter: 0.06 Inch

Device Record Status

Public Device Record Key: 3c0d82a6-06b4-4040-91e6-82d270df6665
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 24, 2016