AccessGUDID - DEVICE: VERUM System Surgical Instrument (08806390860574)

GUDID

Device Identifier (DI) Information

Brand Name: VERUM System Surgical Instrument
Version or Model: PH0913
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jeil Medical Corporation

Primary DI Number: 08806390860574
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688811603 *Terms of Use

Device Description: Bone Fixation Screw Kit

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?
46644	Craniofacial fixation plate kit, non-bioabsorbable	A collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161746	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: 6190e33c-8d92-4b6b-9596-fc9310ea0e89
Public Version Date: November 11, 2019
Public Version Number: 2
DI Record Publish Date: November 15, 2018