AccessGUDID - DEVICE: INSTRUMENT (07613327141597)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 6079-6-510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6079-6-510
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327141597
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: FLAT FLEXIBLE OSTEOTOME BLADE

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 osteotome blade, reusable	A sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on both sides; it is made of high-grade stainless steel. This is a reusable device.

FDA Product Code

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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
Width: 10.0 Millimeter

Device Record Status

Public Device Record Key: 8651c2bc-e118-44de-a77a-18e4977df6cf
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016