HNM Women Care HBI-UIC5FA

GUDID 10842962105242

BELLOTA SONOHYSTEROGRAPHY CATHETER W/CERVICAL CONE, 5 Fr, 350mm, NON-BALLOON, STERILE, BOX OF 25

HNM STAINLESS, LLC.

Hysterosonography/endometrial biopsy catheter
Primary Device ID10842962105242
NIH Device Record Key915638f8-fce5-461e-98c1-f29589154890
Commercial Distribution StatusIn Commercial Distribution
Brand NameHNM Women Care
Version Model NumberHBI-UIC5FA
Catalog NumberHBI-UIC5FA
Company DUNS806754185
Company NameHNM STAINLESS, LLC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842962105245 [Unit of Use]
GS110842962105242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-07
Device Publish Date2019-05-30

On-Brand Devices [HNM Women Care ]

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

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