Identity
- Trade Name
- ReSure Sealant FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Model / Reference
- 5-Up FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00867968000004 FDA UDI
- PMA Number
- P130004 FDA UDI
- FDA Product Code
- PFZ FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
ReSure Sealant by Ocular Therapeutix, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, non-antimicrobial.
- Orasoothe Oral Coating Rinse 4oz – Hygiene — SEPTODONT SAS SPECIALITES SEPTODONT · Class I
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- HydroTac transparent 10x10cm steril P10 — Paul Hartmann Corp. · Class I
- Hyalo4 Care Clear Hydrogel, 100g — Fidia Farmaceutici · U
- CareOne — Ahold U.S.A., Inc. · Class I
- NAR — NORTH AMERICAN RESCUE, LLC. · Class I
- Simpurity — SAFE N SIMPLE LLC · Class I
Cleared under the same submission
P130004 also covers:
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ocular Therapeutix, Inc.
Sources (1)
- FDA UDI ca10e586-459d-44d5-aae0-12f1049b26ae 33 fields · synced Jun 8, 2026