VIOLA FV0239BA310S

GUDID 08800256050406

MEDITIME CO., LTD.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 08800256050406
• NIH Device Record Key: 543fb541-5b8f-4e61-9e6d-61a61ac60ca4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIOLA
• Version Model Number: FV0239BA310S
• Catalog Number: FV0239BA310S
• Company DUNS: 689774482
• Company Name: MEDITIME 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800256050390 [Primary]
GS1	08800256050406 [Package]; Contains: 08800256050390; Package: BOX [4 Units]; In Commercial Distribution
GS1	08800256051120 [Package]; Package: BOX [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190264

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-11
• Device Publish Date: 2024-06-03

On-Brand Devices [VIOLA]

• 08800256050321: DVSSR20070L-20135X
• 08800256050307: DVSSR20100L-20165X
• 08800256050284: DVSSR19100L-00165X
• 08800256050246: DVAGR19100L-00170X
• 08800256050215: DVAGR19070L-00140X
• 08800256050192: DVCHR19038L-00040X
• 08800256050178: DVCGR20070L-20140X
• 08800256050154: DVCGR20100L-20200X
• 08800256050130: DVCGR19100L-00200X
• 08800256050031: DV2044BS10ED
• 08800256050017: DV2029BS10ED
• 08800256050543: DVMXR30025B-60030X
• 08800256050529: DVMXR30025C-60030X
• 08800256050505: DVMXR29038C-60050X
• 08800256050482: DVMXR29025C-60030X
• 08800256050468: DVMXR27060C-50090X
• 08800256050444: DVMXR27038C-50050X
• 08800256050420: FV0257BA310S
• 08800256050406: FV0239BA310S
• 08800256050383: DV0248BS10GD
• 08800256050369: DV0248BSA3GD
• 00880256050345: DV0232BS10GD
• 08800256051069: DVAGR18100L-02170X
• 08800256051014: DVSER19050L-02070X
• 08800256050994: DVNXR19060L-60080X
• 08800256050970: DVNXR19038L-60040X
• 08800256050864: DVMXB23050L-60070X
• 08800256050826: DVTXS26060C-70090X
• 08800256050802: DVTXS26038C-70050X
• 08800256050727: DVMXS29060C-60090X
• 08800256050703: DVMXS29038C-60050X
• 08800256050680: DVMXS29025C-60030X
• 08800256050666: DVMXS26060C-50090X
• 08800256050642: DVMXS26038C-50050X
• 08800256051380: FV0257BA000S