GBR System

GUDID 08800041000036

Surgident Co.,Ltd.

Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08800041000036
• NIH Device Record Key: e5df9a9b-e247-4f35-9b6f-1393a1b502e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GBR System
• Version Model Number: SDS-140-040
• Company DUNS: 689846448
• Company Name: Surgident Co.,Ltd.
• Device Count: 5
• 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: true
• 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	08800041000036 [Primary]
GS1	08800041000296 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170697

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[08800041000036]

Moist Heat or Steam Sterilization

[08800041000036]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-11
• Device Publish Date: 2018-08-31

On-Brand Devices [GBR System]

• 08800041000258: SDP-T44-044
• 08800041000241: SDP-T36-022
• 08800041000234: SDP-T22-015
• 08800041000227: SDP-S44-044
• 08800041000210: SDP-S36-022
• 08800041000203: SDP-S22-015
• 08800041000197: SDS-200-120
• 08800041000180: SDS-200-100
• 08800041000173: SDS-200-080
• 08800041000166: SDS-200-060
• 08800041000159: SDS-200-040
• 08800041000142: SDS-200-030
• 08800041000135: SDS-160-120
• 08800041000128: SDS-160-100
• 08800041000111: SDS-160-080
• 08800041000104: SDS-160-060
• 08800041000098: SDS-160-040
• 08800041000081: SDS-160-030
• 08800041000074: SDS-140-120
• 08800041000067: SDS-140-100
• 08800041000050: SDS-140-080
• 08800041000043: SDS-140-060
• 08800041000036: SDS-140-040
• 08800041000029: SDS-140-030
• 08800041000012: SDB-140-050
• 08800041000005: SDB-140-035