AccessGUDID - DEVICE: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS (05055662917475)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
Version or Model: OS465001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OS465001
Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED

Primary DI Number: 05055662917475
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 218648211 *Terms of Use

Device Description: WASHER 13.0/6.6MM FOR 4.5MM to 7.3MM CANN. SCREW

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):	No
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?
61671	Orthopaedic bone washer, sterile	A sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K110895	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: 84d0ccd4-4ca3-4f37-97ca-8282af6c02a5
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: May 16, 2016