AccessGUDID - DEVICE: Microware Bone Plates and Bone Screws (04719872228226)

GUDID

Device Identifier (DI) Information

Brand Name: Microware Bone Plates and Bone Screws
Version or Model: 297601A-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MICROWARE PRECISION CO., LTD.

Primary DI Number: 04719872228226
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658650833 *Terms of Use

Device Description: ROUND WASHER, OUTSIDE DIAMETER 10.0mm / INSIDE DIAMETER 4.6mm

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?
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NDG	Washer, Bolt, Nut, Non-Spinal, Metallic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111008	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b87a9afb-da23-4732-868d-40de9a3ef172
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: April 07, 2016