Integra® Miltex® 30-3001

GUDID 10381780169918

Silicone Vaginal Dilator Set, Large

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Vaginal dilator

• Primary Device ID: 10381780169918
• NIH Device Record Key: c6384eab-fe40-41a1-ba7c-82388e7ee09e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® Miltex®
• Version Model Number: 30-3001
• Catalog Number: 30-3001
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780169918 [Primary]
HIBCC	H8343030010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003380

FDA Product Code

• HDX: DILATOR, VAGINAL

Sterilization

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

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

[10381780169918]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-08-26

On-Brand Devices [Integra® Miltex®]

• H83422D4200: Blumenthal Rongeur, 6", 3mm Bite, Angled 45°
• H8341481: Bakes Common Duct Dilator, 8-1/2", Set of 9, Sizes 3mm To 11mm
• H834141091: Bakes Common Duct Dilator, 8-1/2", 9mm Diameter
• H834141081: Bakes Common Duct Dilator, 8-1/2", 8mm Diameter
• H834141071: Bakes Common Duct Dilator, 8-1/2", 7mm Diameter
• H834141061: Bakes Common Duct Dilator, 8-1/2", 6mm Diameter
• H834141051: Bakes Common Duct Dilator, 8-1/2", 5mm Diameter
• H834141041: Bakes Common Duct Dilator, 8-1/2", 4mm Diameter
• H834141031: Bakes Common Duct Dilator, 8-1/2", 3mm Diameter
• H8341410111: Bakes Common Duct Dilator, 8-1/2", 11mm Diameter
• H8341410101: Bakes Common Duct Dilator, 8-1/2", 10mm Diameter
• 10381780160298: DeBakey-Satinsky Vena Cava Clamp, 9-1/2", Large, 50mm Jaw, 13mm Deep
• 10381780160274: DeBakey-Satinsky Vena Cava Clamp, 9-1/2", Small, 30mm Jaw, 9mm Deep
• H8343026320: Iowa Trumpet Pudendal Needle Guide 6"
• H834PM500E0: Straight Skin Hook, 6", Small, 2.5mm Hook
• H834PM500D0: Straight Skin Hook, 6", Large, 5mm Hook
• H834PM500C0: Converse Hook, 6", Large, 5mm Hook
• H834PM500A0: Converse Hook, 6", Small, 3mm Hook
• H834PM500B0: Converse Hook, 6", Medium, 4mm Hook
• H834883TC0: Julian pattern Needle Holder 8-1/4", Curved, Serrated Jaws, Tungsten Carbide
• H83430630: Pederson Vaginal Speculum, 7/8" X 4-1/8", Open Sided
• H83463140: Walter Splinter Forceps, 4-1/8", Angled
• H83463180: Feilchenfeld Splinter Forceps, 4-1/2", Serrated
• H8342616240: Scoville Disc Curette, 9-3/4", Angled Down, 4.7mm x 9.5mm Cup
• H8342616200: Scoville Disc Curette, 9-3/4", Angled Up, 4.7mm x 9.5mm Cup
• H83462520: Graft Material Spoon, 4mm Packer
• H834TKM100: Bone Curette, Miller 10, Double, Tactile Tone™
• H834017257050: Ruler, 3", Stainless Steel, Without Clip, Left Hand
• H834017257040: Ruler, 3", Stainless Steel, With Clip, Left Hand
• H834017257030: Ruler, 3", Stainless Steel, Without Clip, Right Hand
• H834017257020: Ruler, 3", Stainless Steel, With Clip, Right Hand
• H834013257130: Thumb Ruler, Left Hand, Stainless Steel
• H834013257120: Thumb Ruler, Right Hand, Stainless Steel
• H834013257110: Finger Ruler, Left Hand, Stainless Steel
• H834013257100: Finger Ruler, Right Hand, Stainless Steel
• H83462760: Bone Harvester, Straight Handle
• H83462750: Bone Harvester, 20 Degree Angled Up Handle
• H83462510: Graft Material Spoon With 3mm Graft Packer
• H834017257010: Ruler, 6" Stainless Steel
• H834017257000: Ruler, 6" Stainless Steel, With Clip
• H834MH2616340: Hibbs-Spratt Curette 9", Oval Cup, Size 3
• H834MH2616320: Hibbs-Spratt Curette 9", Oval Cup, Size 2
• H834MH2616300: Hibbs-Spratt Curette 9", Oval Cup, Size 1
• H834MH2616290: Hibbs-Spratt Curette 9", Oval Cup, size 0
• H834MH2616280: Hibbs-Spratt Curette 9", Oval Cup, Size 2/0
• H834PM06760: Ruler 6", Graduated in mm and inches, with Pocket Clip
• H834MH2616360: Hibbs-Spratt Curette 9", Oval Cup, Size 4
• H83462500: Bone Grafting Material Spoon
• H834PM44460: Hallack Comedone Extractor 6-1/4", Double-Ended
• H834PM13120: Mitchell Trimmer 6-3/4", Double-Ended