AccessGUDID - DEVICE: ORTHOSORB LS1.3mm TAPERED PIN KIT, 1 PIN (00887868130830)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHOSORB LS1.3mm TAPERED PIN KIT, 1 PIN
Version or Model: 110010745
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110010745
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868130830
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVZ	Pin, fixation, resorbable, hard tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140625	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
No Device Sizes

Device Record Status

Public Device Record Key: 86e92640-eb14-454d-8270-9c0aac2306a1
Public Version Date: May 30, 2025
Public Version Number: 9
DI Record Publish Date: October 24, 2015