Integra® Miltex®
GUDID H83430GD21
PESSARY GELHORN WITH DRAIN, SIZE 2
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Pelvic-organ-supporting pessary| Primary Device ID | H83430GD21 |
| NIH Device Record Key | 8aa44e01-cc05-4e57-a024-6de4ce33ddde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® Miltex® |
| Version Model Number | 30-GD2 |
| Company DUNS | 081277700 |
| Company Name | INTEGRA LIFESCIENCES PRODUCTION CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
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| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780170617 [Primary] |
| HIBCC | H83430GD21 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092981
FDA Product Code
| HHW | PESSARY, VAGINAL |
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 | 2020-02-05 |
| 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 |
Trademark Results [Integra]
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