Defend

GUDID 00816577022280

YOUNG MYDENT, LLC

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use

• Primary Device ID: 00816577022280
• NIH Device Record Key: 24ea67fb-5500-4401-9e99-86787fc20992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defend
• Version Model Number: MK-2001
• Company DUNS: 081330555
• Company Name: YOUNG MYDENT, LLC
• 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: true
• Expiration Date: false
• 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	00816577022280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020474

FDA Product Code

• MSH: Respirator,Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-11-11

On-Brand Devices [Defend]

• 00816577022617: STERI-POUCHES 13" x 20" 200/BOX
• 00816577022600: STERI-POUCHES 9" x 15" 200/BOX
• 00816577022594: STERI-POUCHES 7" 1/2" x 13" 200/BOX
• 00816577022587: STERI-POUCHES 5" 1/4" x 10" 200/BOX
• 00816577022570: STERI-POUCHES 3" 1/2" x 10" 200/BOX
• 00816577022563: STERI-POUCHES 3" 1/2" x 10" 500/BOX
• 00816577022556: STERI-POUCHES 3" 1/2" x 5 1/4" 200/BOX
• 00816577022549: STERI-POUCHES 2" 3/4" x 10" 200/BOX
• 00816577022532: STERI-POUCHES 2" x 7 3/4 200/BOX
• 00816577022525: STERI-POUCHES 2 1/4" X 2 3/4 200/BOX
• 00816577022518: STERI-POUCHES 2.25" x 4 200/BOX
• 00816577022433: DISPOSABLE LAB COAT - LARGE (LAVENDER)
• 00816577022426: DISPOSABLE LAB COAT - XXX-LARGE 10/BAG (LAVENDER)
• 00816577022419: DISPOSABLE LAB COAT - XX-LARGE 10/BAG (LAVENDER)
• 00816577022402: DISPOSABLE LAB COAT - X-LARGE 10/BAG (LAVENDER)
• 00816577022389: DISPOSABLE LAB COAT - MEDIUM 10/BAG (LAVENDER)
• 00816577022372: DISPOSABLE LAB COAT - SMALL 10/BAG (LAVENDER)
• 00816577022365: GLIDER BARRIER ENVELOPES SIZE 2 300/BX
• 00816577022358: GLIDER BARRIER ENVELOPES SIZE 0 100/BX
• 00816577022341: GLIDER BARRIER ENVELOPES SIZE 1 100/BX
• 00816577022327: ETCH-GEL 38% KIT
• 00816577022310: MK-3001
• 00816577022303: MK-2010
• 00816577022297: MK-2007
• 00816577022280: MK-2001
• 00816577022273: MK-1410
• 00816577022266: MK-2000
• 00816577022259: MK-N95
• 00816577022181: MK-4046
• 00816577022174: MK-3400
• 00816577022167: MK-3300
• 00816577022150: MK-3200
• 00816577022143: MK-3100
• 00816577022136: MK-1010
• 00816577022129: CS-0101
• 00816577022112: DEFEND DESENSITIZER 10ML
• 00816577022105: PIT & FISSURE SEALANT KIT
• 00816577022099: BF-8900
• 00816577022082: BF-8800
• 00816577022075: BF-8700
• 00816577022068: MK-3500
• 00816577022051: MK-3000
• 00816577022020: MK-1216
• 00816577022013: MK-1206
• 00816577020712: VP-9200
• 00816577020330: MK-1106
• 00816577020323: MK-1076
• 00816577020316: MK-1066
• 00816577020309: MK-1056
• 00816577020293: MK-1046