AccessGUDID - DEVICE: Distraction Screw Pre-Drill (10840199515490)

GUDID

Device Identifier (DI) Information

Brand Name: Distraction Screw Pre-Drill
Version or Model: 7330-35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7330-35
Company Name: KOROS U.S.A., INC.

Primary DI Number: 10840199515490
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007928633 *Terms of Use

Device Description: Tilting Arm Distraction Screw Pre-Drill

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:	No
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?
44579	Assistive laundry clothesline	A technical laundry aid designed to be used by a person with a disability upon which they can hang wet or damp clothing for this to dry. It is designed as a flexible line that can be horizontally tensioned upon which the clothing is hung. It typically consists of several parallel lines held within a holder that is affixed to a wall; the loose end is stretched to a second anchorage point on an adjacent wall when in use. It is typically folded together for convenient storage when not in use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXX	Screwdriver

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 in dry place at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 9x12mm

Device Record Status

Public Device Record Key: 8fe5651d-1121-4e08-ade6-eec61abd9fe8
Public Version Date: January 08, 2025
Public Version Number: 1
DI Record Publish Date: December 31, 2024