Bioteque Taiwan Ltd.

GUDID 04719894430027

Bioteque Taiwan Ltd.

Pelvic-organ-supporting pessary

• Primary Device ID: 04719894430027
• NIH Device Record Key: 315e7ab0-32be-4fe7-ac43-6427e230ee60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bioteque Taiwan Ltd.
• Version Model Number: R2
• Company DUNS: 657769858
• Company Name: Bioteque Taiwan Ltd.
• 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	04719894430027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092981

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: 2024-12-16
• Device Publish Date: 2024-12-06

On-Brand Devices [Bioteque Taiwan Ltd.]

• 04719894432229: DT-A/L
• 04719894432212: DT-A/M
• 04719894432205: DT-A/S
• 04719894433370: RD003-P
• 04719894433011: UI 4.0
• 04719894432885: UMI4.5K
• 04719894432953: UMI4.5
• 04719894432854: BA100
• 04719894432809: UIC5FAX
• 04719894432793: UIC5FA
• 04719894432786: UIC5F
• 04719894432687: BA001
• 04719894432670: BA05F-ST
• 04719894432663: BA071F
• 04719894432656: BA051F
• 04719894432649: BA07F
• 04719894432632: BA05F
• 04719894432557: WC-400MM
• 04719894432496: OS265BA-3
• 04719894432489: OS265BA-2
• 04719894432472: OS265BA-1
• 04719894432403: RD003
• 04719894432328: M0015
• 04719894432311: M0014
• 04719894432304: DT-C
• 04719894432298: DT-B
• 04719894432281: DT-B/XL
• 04719894432274: DT-B/L
• 04719894432267: DT-B/M
• 04719894432250: DT-B/S
• 04719894432243: DT-A
• 04719894432236: DT-A/XL
• 04719894433356: R3
• 04719894433004: UMI4.5-P
• 04719894432991: UMI4.5K-G
• 04719894432984: UMI4.5KC
• 04719894432977: UMI4.5C
• 04719894432335: M0016
• 04719894432076: FS12
• 04719894432069: FS10
• 04719894432052: FS08
• 04719894432045: FS06
• 04719894432038: ID5
• 04719894432021: ID4
• 04719894432014: ID3
• 04719894432007: ID2
• 04719894431994: IR9
• 04719894431987: IR8
• 04719894431970: IR7
• 04719894431963: IR6