Bioteque America, Inc.

GUDID 00810142350440

RING with KNOB (w/o), RK2.25 #2

Bioteque America, Inc.

Pelvic-organ-supporting pessary

• Primary Device ID: 00810142350440
• NIH Device Record Key: 4a6b1c9c-eb2e-4ad5-b42c-875fbc4740ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioteque America, Inc.
• Version Model Number: RK2
• Company DUNS: 785179719
• Company Name: Bioteque America, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810142350440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013289

FDA Product Code

• HHW: Pessary, Vaginal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-02
• Device Publish Date: 2025-05-23

On-Brand Devices [Bioteque America, Inc.]

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