AccessGUDID - DEVICE: DELTA (07613252286417)

GUDID

Device Identifier (DI) Information

Brand Name: DELTA
Version or Model: 73-72284
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 73-72284
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613252286417
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: S-DRILLING TAP, DENT, FOR 4mm SCREW

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
Bone tap, single-use, non-sterile	A non-sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a single-use device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

Bone tap, single-use, non-sterile

A non-sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a single-use device intended to be sterilized prior to use.

FDA Product Code

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Product Code	Product Code Name
DZJ	DRIVER, WIRE, AND BONE DRILL, MANUAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113109	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 50.0 Millimeter
Device Size Text, specify: Diameter: 2.2 Millimeter

Device Record Status

Public Device Record Key: 5ce6c137-6e1f-46f9-b6da-8150167e0348
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 24, 2016