Prometheus System Bone Screw

GUDID 08806390897761

Jeil Medical Corporation

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08806390897761
• NIH Device Record Key: d742f9ac-40b9-4ee0-a648-95801dffd3de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus System Bone Screw
• Version Model Number: PRO-10230
• 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: true
• 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	08806390897761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172008

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

[08806390897761]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-09
• Device Publish Date: 2020-09-01

On-Brand Devices [Prometheus System Bone Screw]

• 08806390898744: PRO-10207
• 08806390898737: PRO-10199
• 08806390898720: PRO-10206
• 08806390898713: PRO-10198
• 08806390898706: PRO-10205
• 08806390898690: PRO-10197
• 08806390898683: PRO-10204
• 08806390898676: PRO-10196
• 08806390898669: PRO-10203
• 08806390898652: PRO-10195
• 08806390898645: PRO-10202
• 08806390898638: PRO-10194
• 08806390898621: PRO-10201
• 08806390898614: PRO-10193
• 08806390898607: PRO-10200
• 08806390898591: PRO-10192
• 08806390898584: PRO-10191
• 08806390898577: PRO-10190
• 08806390898560: PRO-10189
• 08806390898553: PRO-10187
• 08806390898546: PRO-10186
• 08806390898539: PRO-10185
• 08806390898522: PRO-10184
• 08806390898515: PRO-10183
• 08806390898508: PRO-10182
• 08806390898492: PRO-10181
• 08806390898485: PRO-10180
• 08806390898478: PRO-10179
• 08806390898461: PRO-10178
• 08806390898454: PRO-10177
• 08806390898447: PRO-10176
• 08806390898430: PRO-10175
• 08806390898423: PRO-10174
• 08806390898416: PRO-10173
• 08806390898409: PRO-10172
• 08806390898393: PRO-10171
• 08806390898386: PRO-10170
• 08806390898379: PRO-10169
• 08806390898362: PRO-10168
• 08806390898355: PRO-10664
• 08806390898348: PRO-10663
• 08806390898331: PRO-10662
• 08806390898324: PRO-10661
• 08806390898317: PRO-10660
• 08806390898300: PRO-10659
• 08806390898294: PRO-10658
• 08806390898287: PRO-10657
• 08806390898270: PRO-10656
• 08806390898263: PRO-10655
• 08806390898256: PRO-10654