US/GS Ultra Wide System

GUDID 08800000900278

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800000900278
• NIH Device Record Key: 4df1eb13-22d5-4a91-8f29-19550b3bf15a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US/GS Ultra Wide System
• Version Model Number: GSRA7640P
• Company DUNS: 689051793
• Company Name: Osstem Implant Co., Ltd.
• 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: true
• 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	08800000900278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073465

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800000900278]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-23

On-Brand Devices [US/GS Ultra Wide System]

• 08800000900414: AIHW803
• 08800000900407: AIHW805
• 08800000900391: CAW825
• 08800000900384: CAW825TH
• 08800000900377: CAW825WH
• 08800000900360: CAW845
• 08800000900353: CAW845TH
• 08800000900346: CAW845WH
• 08800000900339: GSHAS753
• 08800000900322: GSHAS755
• 08800000900315: GSHAS757
• 08800000900308: GSRA7610P
• 08800000900292: GSRA7620P
• 08800000900285: GSRA7630P
• 08800000900278: GSRA7640P
• 08800000900261: GSRA7650P
• 08800000900254: GSRA8620
• 08800000900247: GSRA8620P
• 08800000900230: GSRA8640
• 08800000900223: GSRA8640P
• 08800000900216: GSRPC760
• 08800000900209: GSRPC860
• 08800000900193: GSTA7610NWH
• 08800000900186: GSTA7610WH
• 08800000900179: GSTA7620NWH
• 08800000900162: GSTA7620WH
• 08800000900155: GSTA7630NWH
• 08800000900148: GSTA7630WH
• 08800000900131: GSTA7640NWH
• 08800000900124: GSTA7640WH
• 08800000900117: GSTA7650NWH
• 08800000900100: GSTA7650WH
• 08800000900094: GSTA8620
• 08800000900087: GSTA8620WH
• 08800000900070: GSTA8640
• 08800000900063: GSTA8640WH