HNM Women Care HBI-BA071F/SGL

GUDID 00842962105276

HSG CATHETER SET W/BALLOON, 7 Fr, SUREFLEX, STERILE

HNM STAINLESS, LLC.

Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter Hysterosonography/endometrial biopsy catheter

• Primary Device ID: 00842962105276
• NIH Device Record Key: 37a5931b-e5fc-4f56-991d-bada68995909
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HNM Women Care
• Version Model Number: HBI-BA071F/SGL
• Catalog Number: HBI-BA071F/SGL
• Company DUNS: 806754185
• Company Name: HNM STAINLESS, LLC.
• 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: 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	00842962105276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092983

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-24
• Device Publish Date: 2019-05-16

On-Brand Devices [HNM Women Care ]

• 00812171029427: PESSARY, RING #4, W/SUPPORT, 2.75"
• 00812171029410: PESSARY, RING #3, W/SUPPORT, 2.5"
• 00812171029403: PESSARY, RING #2, W/SUPPORT, 2.25"
• 00812171029397: PESSARY, RING #1, W/SUPPORT, 2"
• 00812171029380: PESSARY, RING #0, W/SUPPORT, 1.75"
• 00812171029472: PESSARY, RING #9, W/SUPPORT, 4"
• 00812171029465: PESSARY, RING #8, W/SUPPORT, 3.75"
• 00812171029458: PESSARY, RING #7, W/SUPPORT, 3.5"
• 00812171029441: PESSARY, RING #6, W/SUPPORT, 3.25"
• 00812171029434: PESSARY, RING #5, W/SUPPORT, 3"
• 00812171029366: PESSARY, RING #6, W/KNOB AND W/SUPPORT, 3.25"
• 00812171029359: PESSARY, RING #5, W/KNOB AND W/SUPPORT, 3"
• 00812171029342: PESSARY, RING #4, W/KNOB AND W/SUPPORT, 2.75"
• 00812171029335: PESSARY, RING #3, W/KNOB AND W/SUPPORT, 2.5"
• 00812171029328: PESSARY, RING #2, W/KNOB AND W/SUPPORT, 2.25"
• 00812171029311: PESSARY, RING #1, W/KNOB AND W/SUPPORT, 2"
• 00812171029304: PESSARY, RING #0, W/KNOB AND W/SUPPORT, 1.75"
• 00812171029212: PESSARY, RING #9, W/O SUPPORT, 4"
• 00812171029205: PESSARY, RING #8, W/O SUPPORT, 3.75"
• 00812171029199: PESSARY, RING #7, W/O SUPPORT, 3.5"
• 00812171029182: PESSARY, RING #6, W/O SUPPORT, 3.25"
• 00812171029175: PESSARY, RING #5, W/O SUPPORT, 3"
• 00812171029168: PESSARY, RING #4, W/O SUPPORT, 2.75"
• 00812171029151: PESSARY, RING #3, W/O SUPPORT, 2.5"
• 00812171029144: PESSARY, RING #2, W/O SUPPORT, 2.25"
• 00812171029137: PESSARY, RING #1, W/O SUPPORT, 2"
• 00812171029120: PESSARY, RING #0, W/O SUPPORT, 1.75"
• 00812171029373: PESSARY, RING #7, W/KNOB AND W/SUPPORT, 3.5"
• 00812171029298: PESSARY, RING #7, W/KNOB AND W/O SUPPORT, 3.5"
• 00812171029281: PESSARY, RING #6, W/KNOB AND W/O SUPPORT, 3.25"
• 00812171029274: PESSARY, RING #5, W/KNOB AND W/O SUPPORT, 3"
• 00812171029267: PESSARY, RING #4, W/KNOB AND W/O SUPPORT, 2.75"
• 00812171029250: PESSARY, RING #3, W/KNOB AND W/O SUPPORT, 2.5"
• 00812171029243: PESSARY, RING #2, W/KNOB AND W/O SUPPORT, 2.25"
• 00812171029236: PESSARY, RING #1, W/KNOB AND W/O SUPPORT, 2"
• 00812171029229: PESSARY, RING #0, W/KNOB AND W/O SUPPORT, 1.75"
• 00812171029113: PESSARY, OVAL #9, W/SUPPORT, 4”
• 00812171029106: PESSARY, OVAL #8, W/SUPPORT, 3.75”
• 00812171029090: PESSARY, OVAL #7, W/SUPPORT, 3.5”
• 00812171029083: PESSARY, OVAL #6, W/SUPPORT, 3.25”
• 00812171029076: PESSARY, OVAL #5, W/SUPPORT, 3”
• 00812171029069: PESSARY, OVAL #4, W/SUPPORT, 2.75”
• 00812171029052: PESSARY, OVAL #3, W/SUPPORT, 2.5”
• 00812171029045: PESSARY, OVAL #2, W/SUPPORT, 2.25”
• 00812171029038: PESSARY, OVAL #1, W/SUPPORT, 2”
• 00812171029021: PESSARY, OVAL #9, W/O SUPPORT, 4"
• 00812171029014: PESSARY, OVAL #8, W/O SUPPORT, 3.75"
• 00812171029007: PESSARY, OVAL #7, W/O SUPPORT, 3.5"
• 00812171028994: PESSARY, OVAL #6, W/O SUPPORT, 3.25"
• 00812171028987: PESSARY, OVAL #5, W/O SUPPORT, 3"