AccessGUDID - DEVICE: NA (07613154631919)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 5290640100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5290640100
Company Name: STRYKER CORPORATION

Primary DI Number: 07613154631919
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: 4.0 mm ENT Precision Cutter Angle Agg. Serr 60¿ ESSx/HUMMER 4 11.0 cm Working Length

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
Sagittal surgical saw blade, single-use	A sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward. It cuts when the blade is powered in a rapid oscillating (side to side) movement. This type of blade allows a frontal cutting action to be applied within a restricted area. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Sagittal surgical saw blade, single-use

A sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery. This device is designed with the cutting teeth arranged in an arc at the distal end pointing directly forward. It cuts when the blade is powered in a rapid oscillating (side to side) movement. This type of blade allows a frontal cutting action to be applied within a restricted area. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diameter: 4.0 Millimeter
Length: 11.0 Centimeter
Angle: 60.0 degree

Device Record Status

Public Device Record Key: 318e979d-1326-4cc5-bb89-4f202f1f6115
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016