AccessGUDID - DEVICE: eZ-Fix Tool (00841132180686)

GUDID

Device Identifier (DI) Information

Brand Name: eZ-Fix Tool
Version or Model: XFX-625-12L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XFX-625-12L
Company Name: ORTHOPEDIATRICS CORP.

Primary DI Number: 00841132180686
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796416191 *Terms of Use

Device Description: Statix Hardware

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?
62624	Surgical traction tensioner connector	A connecting/extension device intended to be fastened between a surgical traction tensioner/rod/cord and a patient-contact traction device (e.g., orthopaedic bone wire, foot boot, hand wrap/trap) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis). It is intended to be used during a surgical procedure (e.g., fracture reduction, pelvic reconstruction); some types may in addition be used in an orthopaedic bed over a period typically to promote reduction/healing of a fracture. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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: 86ba1510-7278-41bc-99d2-11e1f00e04fc
Public Version Date: March 10, 2020
Public Version Number: 1
DI Record Publish Date: March 02, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(574)268-6379
Email: bsmith@orthopediatrics.com

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