Identity
- Trade Name
- Delphinus Sequr™ FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Delphinus Sequr™ Breast Interface - GEL PAD FDA UDI
- Model / Reference
- Breast Interface FDA UDI
- Description
- Delphinus Sequr™ Breast Interface - GEL PAD FDA UDI
Identifiers
- Catalog Number
- 99-176-780962 FDA UDI
- Primary DI / UDI-DI
- 00855683006579 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Skin topical coupling gel
Delphinus Sequr™ by Parker Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Parker Laboratories, Inc.
Sources (1)
- FDA UDI 2e93365b-42a2-46dd-9d8a-a30fcb93f753 35 fields · synced May 29, 2026