Identity
- Trade Name
- Halo FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Halo Seal Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to cover a wound and to provide a mechanical barrier Each package contains quantity: 1 Halo Seal. FDA UDI
- Model / Reference
- 1216-10006 FDA UDI
- Description
- Halo Seal Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to cover a wound and to provide a mechanical barrier Each package contains quantity: 1 Halo Seal. FDA UDI
Identifiers
- Catalog Number
- 1216-10006 FDA UDI
- Primary DI / UDI-DI
- 00850010608129 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Yes
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
No
FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
Halo by Medical Devices Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CareOne — Ahold U.S.A., Inc. · Class I
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- Simpurity — SAFE N SIMPLE LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medical Devices Inc.
Sources (1)
- FDA UDI 1daa07a9-fbff-4953-aca0-8572a8c1197e 36 fields · synced Jun 6, 2026