OssBuilder System

GUDID 08800000978802

Osstem Implant Co., Ltd.

Extra-gynaecological surgical mesh, metal

• Primary Device ID: 08800000978802
• NIH Device Record Key: 49c9d1be-f2b6-49c8-9f9a-4c04207ea5fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OssBuilder System
• Version Model Number: SM2W12129SB
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com
• Phone: +1(821)012-3412
• Email: chicson@osstem.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800000978802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172354

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-04-05

On-Brand Devices [OssBuilder System]

• 08800000979090: SMHI530USW
• 08800000979083: SMHI530USP
• 08800000979076: SMHI525USW
• 08800000979069: SMHI525USP
• 08800000979052: SMHI520USW
• 08800000979045: SMHI520USP
• 08800000979038: SMHI515USW
• 08800000979021: SMHI515USP
• 08800000979014: SMHI510USW
• 08800000979007: SMHI510USP
• 08800000978994: SMHI430USR
• 08800000978987: SMHI425USR
• 08800000978970: SMHI420USR
• 08800000978963: SMHI415USR
• 08800000978956: SMHI410USR
• 08800000978949: SMHI330USM
• 08800000978932: SMHI325USM
• 08800000978925: SMHI320USM
• 08800000978918: SMHI315USM
• 08800000978901: SMHI310USM
• 08800000978895: SMCC415
• 08800000978734: SBHC5040
• 08800000978727: SBHC5030
• 08800000978710: SBHC4040
• 08800000978703: SBHC4030
• 08800000978697: SBCC4000
• 08800000978680: SBAC4030TSR
• 08800000978673: SBAC4025TSR
• 08800000978666: SBAC4020TSR
• 08800000978659: SBAC4015TSR
• 08800000978642: SBAC4010TSR
• 08800000978635: SBAC4005TSR
• 08800000978628: SBAC4000TSR
• 08800000978611: SBAC3530TSM
• 08800000978604: SBAC3525TSM
• 08800000978598: SBAC3520TSM
• 08800000978581: SBAC3515TSM
• 08800000978574: SBAC3510TSM
• 08800000978567: SBAC3505TSM
• 08800000978550: SBAC3500TSM
• 08800000978420: OBAC533020
• 08800000978413: OBAC532520
• 08800000978406: OBAC532020
• 08800000978390: OBAC531520
• 08800000978383: OBAC531020
• 08800000978376: OBAC530520
• 08800000978369: OBAC530020
• 08800000978352: OBAC503018
• 08800000978345: OBAC502518
• 08800000978338: OBAC502018