AccessGUDID - DEVICE: Precice (00887517028181)

GUDID

Device Identifier (DI) Information

Brand Name: Precice
Version or Model: SFT5-650-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SFT5-650-S
Company Name: NUVASIVE SPECIALIZED ORTHOPEDICS, INC.

Primary DI Number: 00887517028181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 837845234 *Terms of Use

Device Description: 5.0mm x 65mm Screw, Fully Threaded

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
63367	Long bone distraction intramedullary nail, magnetic	An implantable device in the form of a rigid rod, capable of adjusting in length, designed to be inserted into the medullary cavity of a long bone to hold the ends of a fractured bone in position to promote healing, or to support the bone in the presence of a pathological condition, or for limb lengthening procedures (not related to arthrodesis); each rod (nail) is specific to a particular long bone (e.g., femur, humerus, tibia). It consists of telescoping rods connected to the bone by locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device to adjust length.	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 [?]
K193617	000

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: Diameter 5 mm

Device Record Status

Public Device Record Key: 827391b7-0275-41cf-be9a-6b6bf6b82182
Public Version Date: May 28, 2025
Public Version Number: 5
DI Record Publish Date: June 09, 2020