AccessGUDID - DEVICE: Zimmer® Natural Nail™ System (00889024276093)

GUDID

Device Identifier (DI) Information

Brand Name: Zimmer® Natural Nail™ System
Version or Model: 00-2485-090-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-2485-090-10
Company Name: Zimmer GmbH

Primary DI Number: 00889024276093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 488133448 *Terms of Use

Device Description: ZNN CMN LAG SCREW 10.5X90

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34003	Hip internal fixation system	An assembly of implantable devices designed to treat fractures of the hip. It typically includes a metal plate that is held in position with fasteners such as screws and nails, or bolts, nuts and washers. The assembly is typically intended to treat stable or unstable intertrochanteric, pertrochanteric, and/or base of neck hip fractures.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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
Device Size Text, specify: 10.5 MM DIAMETER 90 MM LENGTH

Device Record Status

Public Device Record Key: f9343688-175b-47d3-949d-1334d74601d2
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: October 16, 2015