AccessGUDID - DEVICE: HOFFMANN (04546540701893)

GUDID

Device Identifier (DI) Information

Brand Name: HOFFMANN
Version or Model: 4940-1-015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4940-1-015
Company Name: Stryker Trauma SA

Primary DI Number: 04546540701893
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481999654 *Terms of Use

Device Description: Baltimore Rod To Rod Coupling Compact 5/5mm

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
Orthopaedic instrument connecting screw	A small surgical device designed to join (connect) two additional devices during a surgical procedure (e.g., two surgical instruments or an instrument and an implant) to facilitate the minimally-invasive insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone. It is typically made of high-grade steel and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic instrument connecting screw

A small surgical device designed to join (connect) two additional devices during a surgical procedure (e.g., two surgical instruments or an instrument and an implant) to facilitate the minimally-invasive insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone. It is typically made of high-grade steel and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
JEC	COMPONENT, TRACTION, INVASIVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031941	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
No Device Sizes

Device Record Status

Public Device Record Key: 86e74a6b-f679-4f44-9939-1779add05953
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016