Bioteque America, Inc.

GUDID 00810142350495

RING with KNOB (w/o), RK3.50 #7

Bioteque America, Inc.

Pelvic-organ-supporting pessary
Primary Device ID00810142350495
NIH Device Record Key6edfdb6b-c342-455e-886d-5b44c35253ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioteque America, Inc.
Version Model NumberRK7
Company DUNS785179719
Company NameBioteque America, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810142350495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHWPessary, Vaginal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-23

On-Brand Devices [Bioteque America, Inc.]

00810142350020R2
00810142352369Preferred Curette Sureflex
00810142352253Vaginal Dilator set-A, SET DT-A
00810142350747DISH PESSARY (w/o), DSH50 #0
00810142350228CUBE PESSARY (w/o) ,CU33 #2
00810142352314Vaginal Dilator set-C, SET DT-C
00810142352208PESSARY REMOVER
00810142352086Flexi Shelf Pessary #12, 76mm #12
00810142352079Flexi Shelf Pessary #10
00810142352062Flexi Shelf Pessary #08
00810142352055Flexi Shelf Pessary #06
00810142352048INCONTINENCE RING PESSARY, Inflatable Donut, ID2.75 #5
00810142352031INCONTINENCE RING PESSARY, Inflatable Donut, ID2.50 #4
00810142352024INCONTINENCE RING PESSARY, Inflatable Donut, ID2.25 #3
00810142352017INCONTINENCE RING PESSARY, Inflatable Donut, ID2.00 #2
00810142351911INCONTINENCE RING PESSARY, IR #0
00810142351713HODGE PESSARY(w/o) ,HD65/38 #0
00810142351614GEHRUNG PESSARY (w),GH50S/42 #0
00810142351478MARLAND PESSARY (w/o) ,M2.25 #2
00810142351393SHAATZ PESSARY(w), SH2.00 #2
00810142351386SHAATZ PESSARY(w), SH1.75 #1
00810142351379SHAATZ PESSARY(w), SH1.50 #0
00810142350570RING with KNOB (w), RK3.50S #7
00810142350563RING with KNOB (w), RK3.25S #6
00810142350556RING with KNOB (w), RK3.00S #5
00810142350549RING with KNOB (w), RK2.75S #4
00810142350532RING with KNOB (w), RK2.50S #3
00810142350525RING with KNOB (w), RK2.25S #2
00810142350518RING with KNOB (w), RK2.00S #1
00810142350501RING with KNOB (w), RK1.75S #0
00810142350495RING with KNOB (w/o), RK3.50 #7
00810142350488RING with KNOB (w/o), RK3.25 #6
00810142350471RING with KNOB (w/o), RK3.00 #5
00810142350464RING with KNOB (w/o), RK2.75 #4
00810142350457RING with KNOB (w/o), RK2.50 #3
00810142350440RING with KNOB (w/o), RK2.25 #2
00810142350433RING with KNOB (w/o), RK2.00 #1
00810142350426RING with KNOB (w/o), RK1.75 #0
00810142350419CUBE PESSARY (w), CU75D #10
00810142350402CUBE PESSARY (w), CU70D #9
00810142350396CUBE PESSARY (w), CU63D #8
00810142350389CUBE PESSARY (w), CU56D #7
00810142350372CUBE PESSARY (w), CU50D #6
00810142350365CUBE PESSARY (w), CU45D #5
00810142350358CUBE PESSARY (w), CU41D #4
00810142350341CUBE PESSARY (w), CU37D #3
00810142350327CUBE PESSARY(w) ,CU29D #1
00810142350310CUBE PESSARY(w) ,CU25D #0
00810142350303CUBE PESSARY (w/o), CU75 #10
00810142350297CUBE PESSARY (w/o), CU70 #9

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