SIGNIA 10936812

GUDID 04038953847218

HA PROMPT P BG HEARING AID

Ws Audiology Usa, Inc.

Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 04038953847218
• NIH Device Record Key: f047f9e9-b7d9-40a7-b902-bf0cd456532a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNIA
• Version Model Number: PROMPT P
• Catalog Number: 10936812
• Company DUNS: 157412271
• Company Name: Ws Audiology Usa, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04038953847218 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

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: 2024-03-25
• Device Publish Date: 2024-03-17

On-Brand Devices [SIGNIA]

• 05714880154481: Signia Pure 312 2AX / SLH
• 05714880154474: Signia Pure 312 2AX / SB
• 05714880154467: Signia Pure 312 2AX / RGD
• 05714880154450: Signia Pure 312 2AX / PRL
• 05714880154443: Signia Pure 312 2AX / GPH
• 05714880154436: Signia Pure 312 2AX / FGD
• 05714880154429: Signia Pure 312 2AX / DKC
• 05714880154412: Signia Pure 312 2AX / DBR
• 05714880154405: Signia Pure 312 2AX / BLK
• 05714880154399: Signia Pure 312 2AX / BG
• 05714880154382: Signia Pure 312 1AX / SLH
• 05714880154375: Signia Pure 312 1AX Hearing Aid / BG
• 05714880154368: Signia Pure 312 1AX / SB
• 05714880154351: Signia Pure 312 1AX / RGD
• 05714880154344: Signia Pure 312 1AX/ PRL
• 05714880154337: Signia Pure 312 1AX / GPH
• 05714880154320: Signia Pure 312 1AX/ FGD
• 05714880154313: Signia Pure 312 1AX/ DKC
• 05714880154306: Signia Pure 312 1AX/ DBR
• 05714880144499: HA PURE C&G 2AX SLH
• 05714880144482: HA PURE C&G 2AX SB
• 05714880144475: HA PURE C&G 2AX RGD
• 05714880144468: HA PURE C&G 2AX PRL
• 05714880144451: HA PURE C&G 2AX GPH
• 05714880144444: HA PURE C&G 2AX / FGD
• 05714880144437: HA PURE C&G 2AX / DKC
• 05714880144420: HA PURE C&G 2AX / DBR
• 05714880144413: HA PURE C&G 2AX / BLK
• 05714880144406: HA PURE C&G 2AX BG
• 05714880144390: HA PURE C&G 1AX / BLK
• 05714880144383: HA PURE C&G 1AX / DBR
• 05714880144376: HA PURE C&G 1AX / DKC
• 05714880144369: HA PURE C&G 1AX / GPH
• 05714880144352: HA PURE C&G 1AX / PRL
• 05714880144345: HA PURE C&G 1AX / RGD
• 05714880144338: HA PURE C&G 1AX / SB
• 05714880144321: HA PURE C&G 1AX / SLH
• 05714880144314: HA PURE C&G 1AX / BG
• 05714880144307: HA PURE C&G 1AX / FGD
• 05714880141313: HA STYLETTO 2AX SNW SLV
• 05714880141023: HA STYLETTO 1AX S BLK SLV
• 05714880141016: HA STYLETTO 1AX S SNW SLV
• 05714880141009: HA STYLETTO 2AX S BLK SLV
• 05714880140996: HA STYLETTO 2AX S SNW SLV
• 05714880129519: Signia Insio C&G 2AX ITE Hearing Aid
• 05714880129502: Signia Insio C&G 1AX ITE Hearing Aid
• 05714880129496: Signia Insio C&G 1AX ITC Hearing Aid
• 05714880129489: Signia Insio C&G 2AX ITC Hearing Aid
• 05714880127744: HA PURE C&G T 2AX SLH
• 05714880127737: HA PURE C&G T 2AX SB