Defend SP-5500

GUDID 20843471153073

Sterilization Pouches 9 Inch x 15 Inch

Young Innovations, Inc.

Sterilization packaging, single-use

• Primary Device ID: 20843471153073
• NIH Device Record Key: 2b2b87ae-2e4f-40a8-9e9f-f154d57f701f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defend
• Version Model Number: SP-5500
• Catalog Number: SP-5500
• Company DUNS: 004193103
• Company Name: Young Innovations, Inc.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com
• Phone: +1 (800) 275-0020
• Email: customerservice@defend.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843471153079 [Primary]
GS1	10843471153076 [Package]; Contains: 00843471153079; Package: Box [200 Units]; In Commercial Distribution
GS1	20843471153073 [Package]; Contains: 10843471153076; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143637

FDA Product Code

• FRG: Wrap, sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-30

On-Brand Devices [Defend]

• 20843471153875: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Fast Set Heavy Body
• 20843471153868: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Fast Set Monophase
• 10843471153854: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Fast Set Medium Body
• 20843471153844: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Fast Set Light Body
• 20843471153837: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Regular Heavy Body
• 20843471153820: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Regular Monophase
• 20843471153813: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Regular Medium Body
• 10843471153809: Super Hydrophilic Vinyl Polysiloxane IMPRESSION MATERIAL - Regular Light Body
• 10843471153083: Sterilization Pouches 13 Inch x 20 Inch
• 20843471153073: Sterilization Pouches 9 Inch x 15 Inch
• 10843471153069: Sterilization Pouches 7.5 Inch x 13 Inch
• 10843471153052: Sterilization Pouches 5.25 Inch x 10 Inch
• 20843471153042: Sterilization Pouches 3.5 Inch x 10 Inch
• 20843471153035: Sterilization Pouches 3.5 Inch x 10 Inch VALUE-PACK
• 20843471153028: Sterilization Pouches 3.5 Inch x 5.25 Inch
• 10843471153014: Sterilization Pouches 2.75 Inch x 10 Inch
• 10843471153007: Sterilization Pouches 2 Inch x 7.75 Inch
• 10843471152994: Sterilization Pouches 2.25 Inch x 2.75 Inch
• 10843471152987: Sterilization Pouches 2.25 Inch x 4 Inch
• 20843471152977: Alginate Replacement Impression Material
• 10843471152963: Vinyl Polysiloxane Impression Material Fast Set - Putty
• 10843471152956: Vinyl Polysiloxane Impression Material Regular Set - Putty
• 10843471152949: High Durometer Vinyl Polysiloxane Derivative
• 20843471152939: Bite Registration Material Vinylpolysiloxane Derivative Hard-Bite Fast Set Unflavored
• 10843471152925: Bite Registration Material Vinylpolysiloxane Derivative Super Fast Set Mint Chocolate Chip
• 10843471152918: Bite Registration Material Vinylpolysiloxane Derivative Fast Set Mint Chocolate Chip
• 20843471152908: Bite Registration Material Vinylpolysiloxane Derivative Super Fast Set Unflavored
• 10843471152895: Bite Registration Material Vinylpolysiloxane Derivative Fast Set Unflavored
• 10843471152888: Bite Registration Material Vinylpolysiloxane Derivative Regular Set Unflavored
• 20843471152786: Cotton Filled Gauze Sponges Non-Sterile 2 Inchx2 Inch 8-PLY
• 10843471150143: Glider Barrier Envelopes for phosphor storage plate
• 10843471147785: Tie-Back Protective Gowns Disposable/Limited Re-Use Large
• 20843471147775: Tie-Back Protective Gowns Disposable/Limited Re-Use Medium
• 10843471147747: Autoclave Tape For Steam and Chemical Vapor Sterilizers 1 Inch x 60 yds
• 10843471147730: Autoclave Tape For Steam and Chemical Vapor Sterilizers .5" x 60 yds
• 10843471147723: Autoclave Tape For Steam and Chemical Vapor Sterilizers 0.75" x 60 yds
• 10843471147679: BITE REG. SUPER FAST-SET CARTRIDGE
• 10843471143923: T-Mixer Brown Tip 1:1 Ratio Core Material
• 10843471132200: Ultra Absorbent 4-PLY PATIENT BIBS 13 Inch x 18 Inch 3-Ply Tissue + 1-Ply Poly Blue
• 10843471131722: Disposable Sterilization Wrap (CSR) 30 Inch x 30 Inch
• 10843471131715: Disposable Sterilization Wrap (CSR) 24 Inch x 24 Inch
• 10843471131708: Disposable Sterilization Wrap (CSR) 20 Inch x 20 Inch
• 10843471131692: Disposable Sterilization Wrap (CSR) 15 Inch x 15 Inch
• 10843471131647: Intra-Oral Tips - Large Clear
• 10843471131302: Non-Sterile Tongue Depressors - Adult 6 Inch (15cm)
• 10843471131296: Surgical Aspirator Tips 1/16 Inch Diameter Blue
• 20843471131286: Surgical Aspirator Tips 1/4 Inch Diameter Green
• 20843471131279: Surgical Aspirator Tips 1/8 Inch Diameter White
• 10843471130992: Barrier Envelopes for phosphor storage plate Size 1
• 10843471130985: Barrier Envelopes for phosphor storage plate Size 0