MILEX

GUDID 60888937008298

KIT: Regula Folding Pessary #6; 2 5/8" x 2 1/8" (67mm x 54mm)

Coopersurgical, Inc.

Pelvic-organ-supporting pessary

• Primary Device ID: 60888937008298
• NIH Device Record Key: 6b455dc8-32ba-4c64-9ea2-16282cef28bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MILEX
• Version Model Number: MXKPREG06
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	60888937008298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904026

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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-07-29

On-Brand Devices [MILEX]

• 60888937014404: MILEX Pessary Kit
• 60888937013308: MILEX Pessary Fitting Kit
• 60888937012738: MILEX Pessary Fitting Kit
• 60888937009271: KIT: Shaatz Folding Pessary; 3 3/4" (95mm)
• 60888937009264: KIT: Shaatz Folding Pessary; 3 1/2" (89mm)
• 60888937009257: KIT: Shaatz Folding Pessary; 3 1/4" (83mm)
• 60888937009240: KIT: Shaatz Folding Pessary; 3" (76mm)
• 60888937009233: KIT: Shaatz Folding Pessary; 2 3/4" (70mm)
• 60888937009226: KIT: Shaatz Folding Pessary; 2 1/2" (64mm)
• 60888937009219: KIT: Shaatz Folding Pessary; 2 1/4" (57mm)
• 60888937009202: KIT: Shaatz Folding Pessary; 2" (51mm)
• 60888937009196: KIT: Shaatz Folding Pessary; 1 3/4" (44mm)
• 60888937009189: KIT: Shaatz Folding Pessary; 1 1/2" (38mm)
• 60888937009073: KIT: Ring with support with knob folding Pessary #13; 5" (127mm)
• 60888937009066: KIT: Ring with support with knob folding Pessary #12; 4 3/4" (121mm)
• 60888937009059: KIT: Ring with support with knob folding Pessary #11; 4 1/2" (114mm)
• 60888937009042: KIT: Ring with support with knob folding Pessary #10; 4 1/4" (108mm)
• 60888937009035: KIT: Ring with support with knob folding Pessary #9; 4" (102mm)
• 60888937009028: KIT: Ring with support with knob folding Pessary #8; 3 3/4" (95mm)
• 60888937009011: KIT: Ring with support with knob folding Pessary #7; 3 1/2" (89mm)
• 60888937009004: KIT: Ring with support with knob folding Pessary #6; 3 1/4" (83mm)
• 60888937008991: KIT: Ring with support with knob folding Pessary #5; 3" (76mm)
• 60888937008984: KIT: Ring with support with knob folding Pessary #4; 2 3/4" (70mm)
• 60888937008977: KIT: Ring with support with knob folding Pessary #3; 2 1/2" (64mm)
• 60888937008960: KIT: Ring with support with knob folding Pessary #2; 2 1/4" (57mm)
• 60888937008953: KIT: Ring with support with knob folding Pessary #1; 2" (51mm)
• 60888937008946: KIT: Ring with support with knob folding Pessary #0; 1 3/4" (44mm)
• 60888937008793: KIT: Ring with support folding Pessary #13; 5" (127mm)
• 60888937008786: KIT: Ring with support folding Pessary #12; 4 3/4" (121mm)
• 60888937008779: KIT: Ring with support folding Pessary #11; 4 1/2" (114mm)
• 60888937008762: KIT: Ring with support folding Pessary #10; 4 1/4" (108mm)
• 60888937008755: KIT: Ring with support folding Pessary #9; 4" (102mm)
• 60888937008748: KIT: Ring with support folding Pessary #8; 3 3/4" (95mm)
• 60888937008731: KIT: Ring with support folding Pessary #7; 3 1/2" (89mm)
• 60888937008724: KIT: Ring with support folding Pessary #6; 3 1/4" (83mm)
• 60888937008717: KIT: Ring with support folding Pessary #5; 3" (76mm)
• 60888937008700: KIT: Ring with support folding Pessary #4; 2 3/4" (70mm)
• 60888937008694: KIT: Ring with support folding Pessary #3; 2 1/2" (64mm)
• 60888937008687: KIT: Ring with support folding Pessary #2; 2 1/4" (57mm)
• 60888937008670: KIT: Ring with support folding Pessary #1; 2" (51mm)
• 60888937008663: KIT: Ring with support folding Pessary #0; 1 3/4" (44mm)
• 60888937008519: KIT: Risser Folding Pessary #9; 4 1/8" x 3 3/8" (105mm x 86mm)
• 60888937008502: KIT: Risser Folding Pessary #8; 3 7/8" x 3 7/16" (98mm x 87mm)
• 60888937008496: KIT: Risser Folding Pessary #7; 3 1/2" x 3 5/16" (89mm x 84mm)
• 60888937008489: KIT: Risser Folding Pessary #6; 3 1/2" x 2 7/8" (89mm x 73mm)
• 60888937008472: KIT: Risser Folding Pessary #5; 3 1/16" x 3 1/8" (78mm x 79mm)
• 60888937008465: KIT: Risser Folding Pessary #4; 2 7/8" x 2 3/4" (73mm x 70mm)
• 60888937008458: KIT: Risser Folding Pessary #3; 2 3/8" x 2 5/8" (60mm x 67mm)
• 60888937008441: KIT: Risser Folding Pessary #2; 2 3/4" x 2 1/2" (70mm x 64mm)
• 60888937008434: KIT: Risser Folding Pessary #1; 2 3/4" x 2 7/16" (70mm x 62mm)