AccessGUDID - DEVICE: Enztec Femoral Impactor

GUDID

Device Identifier (DI) Information

Brand Name: Enztec Femoral Impactor - DJO
Version or Model: 800-05-035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-05-035
Company Name: ENZTEC LIMITED

Primary DI Number: 09421028110624
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 592616445 *Terms of Use

Device Description: A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
32856	Orthopaedic implant impactor, reusable	A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWA	Impactor

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
No Device Sizes

Device Record Status

Public Device Record Key: 9605ccf1-18ac-4748-acb5-b34b831daea5
Public Version Date: February 21, 2023
Public Version Number: 1
DI Record Publish Date: February 13, 2023