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 surgical connector	A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic instrument surgical connector

A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). 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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 86e74a6b-f679-4f44-9939-1779add05953
Public Version Date: December 07, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016