AccessGUDID - DEVICE: 7.3mm Cannulated Screw, Long Threaded (06942782409197)

GUDID

Device Identifier (DI) Information

Brand Name: 7.3mm Cannulated Screw, Long Threaded
Version or Model: 060070105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 060070105
Company Name: Double Medical Technology Inc.

Primary DI Number: 06942782409197
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529366055 *Terms of Use

Device Description: No description.

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?
55895	Haemoglobin E (HbE) IVD , control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype E (HbE) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, Fixation, Bone
HRS	Plate, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130108	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
Length: 105.0 Millimeter
Device Size Text, specify: Minor diameter: 4.5mm
Device Size Text, specify: Major diameter: 7.3mm

Device Record Status

Public Device Record Key: fbc67e69-b604-4f38-bf72-62d94af1ccb8
Public Version Date: September 19, 2024
Public Version Number: 5
DI Record Publish Date: September 01, 2016