Surgical Instrument

GUDID 08809282819933

Jeil Medical Corporation

Orthopaedic implant aiming/guiding block, reusable

• Primary Device ID: 08809282819933
• NIH Device Record Key: 475373fb-abc1-4bc2-9b66-121529bb8ef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Instrument
• Version Model Number: 111-082-L
• 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	08809282819933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191972

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[08809282819933]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-09
• Device Publish Date: 2019-11-29

On-Brand Devices [Surgical Instrument]

• 08806390878807: 112-081(M)
• 08806390878791: 111-010(M)
• 08806390878784: 112-060(M)
• 08809282819957: 111-083-L
• 08809282819940: 111-083-R
• 08809282819933: 111-082-L
• 08809282819926: 111-082-R
• 08806390879101: 112-129
• 08806390876285: 111-230-R
• 08806390876278: 111-230-L
• 08806390876261: 111-229-R
• 08806390876254: 111-229-L
• 08806390876247: 111-228-R
• 08806390876230: 111-228-L
• 08806390876223: 111-227-R
• 08806390876216: 111-227-L
• 08806390876209: 111-226
• 08806390801423: 111-095-R
• 08806390801416: 111-095-L
• 08809282815690: 112-074
• 08806390822633: 910.14AS01
• 08806390850759: 112-120
• 08806390883733: 112-129-7
• 08806390883726: 112-129-6
• 08806390883719: 112-129-5
• 08806390877831: 112-129-4
• 08806390877824: 112-129-3
• 08806390884006: LS-420
• 08809282819841: 112-087
• 08806390874298: 111-206
• 08806390810326: 114-009
• 08806390810302: 114-007
• 08809282819902: 111-089
• 08809282819872: 111-085
• 08809282819865: 111-084
• 08809282818813: 111-087
• 08809282818806: 111-086
• 08809282818745: 111-080
• 08809282815591: 111-060
• 08809282815584: 111-059
• 08809282815577: 111-058
• 08809282815560: 111-057
• 08809282815553: 111-056
• 08809282815546: 111-055
• 08809282815492: 111-068-4
• 08809282815485: 111-068-3
• 08809282815478: 111-068-2
• 08809282815461: 111-068-1
• 08809282811722: 111-047
• 08809282811715: 111-046