AccessGUDID - DEVICE: NA (04546540790934)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 2000-004-045
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2000-004-045
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540790934
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: DRILL COLLAR, 8MM

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:	No
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

[?]

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

GMDN Preferred Term Name	GMDN Definition
Orthopaedic implant/instrument adaptor, reusable	A connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant/instrument adaptor, reusable

A connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Lumen/Inner Diameter: 8.0 Millimeter

Device Record Status

Public Device Record Key: d1e01eed-ff4a-479b-90ae-ea64b33f82d3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 09, 2015