VERUM System Surgical Instrument

GUDID 08806390860574

Bone Fixation Screw Kit

Jeil Medical Corporation

Craniofacial fixation plate kit, non-bioabsorbable

• Primary Device ID: 08806390860574
• NIH Device Record Key: 6190e33c-8d92-4b6b-9596-fc9310ea0e89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERUM System Surgical Instrument
• Version Model Number: PH0913
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806390860574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161746

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806390860574]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-11
• Device Publish Date: 2018-11-15

On-Brand Devices [VERUM System Surgical Instrument]

• 08806390860680: Bone Fixation Screw Kit
• 08806390860673: Bone Fixation Screw Kit
• 08806390860666: Bone Fixation Screw Kit
• 08806390860659: Bone Fixation Screw Kit
• 08806390860642: Bone Fixation Screw Kit
• 08806390860635: Bone Fixation Screw Kit
• 08806390860628: Bone Fixation Screw Kit
• 08806390860611: Bone Fixation Screw Kit
• 08806390860604: Bone Fixation Screw Kit
• 08806390860598: Bone Fixation Screw Kit
• 08806390860581: Bone Fixation Screw Kit
• 08806390860574: Bone Fixation Screw Kit
• 08806390860567: Bone Fixation Screw Kit
• 08806390860550: Bone Fixation Screw Kit
• 08806390860543: Bone Fixation Screw Kit
• 08806390860536: Bone Fixation Screw Kit
• 08806390860529: Bone Fixation Screw Kit
• 08806390860512: Bone Fixation Screw Kit
• 08806390860505: Bone Fixation Screw Kit
• 08806390860499: Bone Fixation Screw Kit
• 08806390860482: Bone Fixation Screw Kit
• 08806390860475: Bone Fixation Screw Kit
• 08806390860468: Bone Fixation Screw Kit
• 08806390860451: Bone Fixation Screw Kit
• 08806390860444: Bone Fixation Screw Kit
• 08806390860437: Bone Fixation Screw Kit
• 08806390860420: Bone Fixation Screw Kit
• 08806390860413: Bone Fixation Screw Kit
• 08806390860406: Bone Fixation Screw Kit
• 08806390860390: Bone Fixation Screw Kit
• 08806390876162: VL0070
• 08806390876018: VL0040
• 08806390876001: VL0030
• 08806390873819: VH0060
• 08806390873802: VH0050
• 08806390873796: VH0040
• 08806390873789: VH0030
• 08806390873772: VH0020
• 08806390873352: VF0060
• 08806390873345: VF0050
• 08806390873338: VF0040
• 08806390873321: VF0030
• 08806390873314: VF0020
• 08806390873307: VF0010
• 08806390872003: VD0040
• 08806390871990: VD0030
• 08806390871983: VD0020
• 08806390871433: VC0060
• 08806390871426: VC0050
• 08806390870733: CC0350