Premier

GUDID D6911040203

GELLHORN PESSARY #3

PREMIER DENTAL PRODUCTS COMPANY

Pelvic-organ-supporting pessary

• Primary Device ID: D6911040203
• NIH Device Record Key: 2d82eb9f-7c9f-4c83-8f0b-e22c048dea41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier
• Version Model Number: 1040203
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: false
• 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
HIBCC	D6911040203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031463

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: 2016-09-16

On-Brand Devices [Premier]

• 00856402006344: Decan Stopper Size 9 Closure Full
• 00856402006337: Decan Stopper Size 8 Closure Full
• 00856402006320: Decan Stopper Size 7 Closure Full
• 00856402006313: Decan Stopper Size 6 Closure Full
• 00856402006306: Decan Stopper Size 5 Closure Full
• 00856402006290: Decan Stopper Size 4 Closure Full
• 00856402006283: Decan Stopper Size 3 Closure Full
• 00856402006276: Decan Stopper Size 2 Closure Full
• 00856402006269: Decan Stopper Size 1 Closure Full
• 00856402006252: Decan Stopper Size 0 Closure Full
• 00856402006245: Decan Stopper Size 9 Closure 3/4
• 00856402006238: Decan Stopper Size 8 Closure 3/4
• 00856402006221: Decan Stopper Size 7 Closure 3/4
• 00856402006214: Decan Stopper Size 6 Closure 3/4
• 00856402006207: Decan Stopper Size 0 Closure 3/4
• 00856402006191: Decan Stopper Size 8 Closure 1/2
• 00856402006184: Decan Stopper Size 7 Closure 1/2
• 00856402006177: Decan Stopper Size 6 Closure 1/2
• 00856402006160: Decan Stopper Size 5 Closure 1/2
• 00856402006153: Decan Stopper Size 0 Closure 1/2
• 00856402006146: Decan Stopper Size 7 Closure 1/4
• 00856402006139: Decan Stopper Size 6 Closure 1/4
• 00856402006122: Decan Stopper Size 5 Closure 1/4
• 00856402006115: Decan Stopper Size 4 Closure 1/4
• 00856402006108: TT Air-Lon® Inhalation Set Sz 8
• 00856402006092: TT Air-Lon® Inhalation Set Sz 7
• 00856402006085: TT Air-Lon® Inhalation Set Sz 6
• 00856402006078: TT Air-Lon® Inhalation Set Sz 4
• 00856402006061: TT Air-Lon® Sz 8
• 00856402006054: TT Air-Lon® Sz 7
• 00856402006047: TT Air-Lon® Sz 6
• 00856402006030: TT Air-Lon® Sz 5
• 00856402006016: TT Air-Lon® Sz 4
• D6913001470: NEXTEMP CEMENT BULK KIT
• D6911040600: PESSARY FITTING SET (6)
• D6911040421: CUBE PESSARY W/O DRAINAGE HOLES #10
• D6911040420: CUBE PESSARY W/ DRAINAGE HOLES #10
• D6911040419: CUBE PESSARY W/O DRAINAGE HOLES #9
• D6911040418: CUBE PESSARY W/O DRAINAGE HOLES #8
• D6911040417: CUBE PESSARY W/O DRAINAGE HOLES #7
• D6911040416: CUBE PESSARY W/O DRAINAGE HOLES #6
• D6911040415: CUBE PESSARY W/O DRAINAGE HOLES #5
• D6911040414: CUBE PESSARY W/O DRAINAGE HOLES #4
• D6911040413: CUBE PESSARY W/O DRAINAGE HOLES #3
• D6911040412: CUBE PESSARY W/O DRAINAGE HOLES #2
• D6911040411: CUBE PESSARY W/O DRAINAGE HOLES #1
• D6911040410: CUBE PESSARY W/O DRAINAGE HOLES #0
• D6911040409: CUBE PESSARY W/ DRAINAGE HOLES #9
• D6911040408: CUBE PESSARY W/ DRAINAGE HOLES #8
• D6911040407: CUBE PESSARY W/ DRAINAGE HOLES #7