AccessGUDID - DEVICE: INSTRUMENT (07613327182439)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 0939-2-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0939-2-100
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327182439
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: EXETER STEM INTRODUCER FOR ANTERIOR APPROACH

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 inserter/extractor	A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant inserter/extractor

A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWL	Prosthesis, hip, hemi-, femoral, metal
HWC	Screw, fixation, bone
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented

FDA Premarket Submission

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

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: 1a3bc079-f2a6-4875-b0d5-73408b4dab28
Public Version Date: December 07, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016