AccessGUDID - DEVICE: Tatum Surgical Bone Fixation Screw Kit (00083208000003)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Surgical Bone Fixation Screw Kit
Version or Model: E-Z bone Fixation Screw Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EZ-Bone Fixation Screw Kit
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208000003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocks Tatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
61837	Craniofacial bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DZL	Screw, Fixation, Intraosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141764	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: 3cd90f1b-78f6-4cc7-a6b8-7356ba4cdfac
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: November 13, 2020