AccessGUDID - DEVICE: Zimmer® Natural Nail® System (00889024298422)

GUDID

Device Identifier (DI) Information

Brand Name: Zimmer® Natural Nail® System
Version or Model: 47-2485-085-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 47-2485-085-10
Company Name: Zimmer GmbH

Primary DI Number: 00889024298422
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 10.5X85

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
66946	Femoral neck fixation sliding bone screw	A dedicated, partially-threaded rod intended to be implanted through the sleeve of a femoral neck fixation plate/sleeve (not included) and into the neck and head of the femur to treat a trochanteric fracture. It is commonly referred to as a dynamic hip screw or lag screw, however it has no screw head, but instead includes a female thread at the proximal end to accept a compression screw.	Active	true

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: ø 10.5 mm 85 mm length

Device Record Status

Public Device Record Key: b48f03e7-9b0d-4ddd-9a7b-d2554bea8458
Public Version Date: July 25, 2024
Public Version Number: 6
DI Record Publish Date: October 23, 2015