MINT

GUDID 18809556174314

Hans Biomed Corp.

Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial

• Primary Device ID: 18809556174314
• NIH Device Record Key: a1956a5c-865e-49f2-b89e-fb9beb1752e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MINT
• Version Model Number: MINT 12WC1985
• Company DUNS: 689512625
• Company Name: Hans Biomed Corp.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809556174317 [Primary]
GS1	18809556174314 [Package]; Contains: 08809556174317; Package: Box Package [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130191

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: 2020-03-31
• Device Publish Date: 2020-03-23

On-Brand Devices [MINT]

• 18809556174413: MINT 15WC1810
• 18809556174338: MINT 40LC1940
• 18809556174321: MINT 95LC1960
• 18809556174314: MINT 12WC1985
• 08809556174300: MINT MT 15WC1810
• 18809556174291: MINT 60WC1960
• 18809556174468: MINT 40LC1940
• 18809779584549: MINT 14WC1985
• 08809204330386: MINT MINI-S 1013
• 08809204330379: MINT 43BN1913
• 08809204330348: MINI-S 1017
• 08809204330331: ML1043
• 08809556174454: MINT lift ML 1043
• 08809556174447: MINT lift MINI-S 1017
• 08809556174423: MINT 43BN1913
• 18809779585911: MINT-I 15WC1810
• 18809779585904: MINT-I 14WC1985
• 18809779585935: MINT-I 18WC1810
• 18809779585928: MINT-I 15WC1985
• 08809779586102: MINT-I 17WC1710A
• 18809779586512: MINT-I MT 15WC1810
• 18809779586505: MINT-I 95LC1960
• 18809779586499: MINT-I 60WC1960
• 18809779586482: MINT-I 40LC1940