AccessGUDID - DEVICE: OsteoMed (00845694031592)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoMed
Version or Model: 316-0025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 316-0025
Company Name: OSTEOMED LLC

Primary DI Number: 00845694031592
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 606417780 *Terms of Use

Device Description: Washer for 6.5/7.3mm Screws

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?
36198	Orthopaedic bone washer	A flat thin ring or plate typically used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. The washer 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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Store at controlled room temperature out of direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 12.4 Millimeter

Device Record Status

Public Device Record Key: 74c88f19-5a0c-479f-abfc-ae02d76e8cdd
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 24, 2015