AccessGUDID - DEVICE: Leith Medical Plating System Instruments (B953900200080)

GUDID

Device Identifier (DI) Information

Brand Name: Leith Medical Plating System Instruments
Version or Model: 9002-0008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Leith Medical LLC

Primary DI Number: B953900200080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062982676 *Terms of Use

Device Description: Screw Removal tool

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?
62358	Screw extractor, reusable	A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.	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 [?]
K200062	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: 3.5 Inch

Device Record Status

Public Device Record Key: d4a6e772-d5d6-49d4-a89d-2753428f266b
Public Version Date: October 16, 2023
Public Version Number: 1
DI Record Publish Date: October 06, 2023