Halo 1216-10010
GUDID 00850010608075
Halo Seal 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: 2 Halo Seals.
Medical Devices Inc
Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial| Primary Device ID | 00850010608075 |
| NIH Device Record Key | 2e3ae197-da36-4393-a303-6df4688af99e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Halo |
| Version Model Number | 1216-10010 |
| Catalog Number | 1216-10010 |
| Company DUNS | 101571834 |
| Company Name | Medical Devices 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850010608068 [Primary] |
| GS1 | 00850010608075 [Package] Contains: 00850010608068 Package: [200 Units] In Commercial Distribution |
FDA Product Code
| NAD | Dressing, Wound, Occlusive |
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 | 2021-03-10 |
| Device Publish Date | 2021-03-02 |
On-Brand Devices [Halo]
| 00850010608150 | Halo Vent Combo IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, |
| 00850010608136 | Halo Seal Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing |
| 00850010608112 | Halo Vent Single IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing |
| 00850010608099 | Halo Vent 2 Pack IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing |
| 00850010608075 | Halo Seal IFAK. This device is a non-resorbable and non-sterile, occlusive wound dressing, inten |
| 00850010608051 | Halo XL. This device is a non-resorbable and non-sterile, occlusive wound dressing, intended to |
| 00850010608037 | Halo Vent Combo Flat Package. This device is a non-resorbable and non-sterile, occlusive wound d |
| 00850010608013 | Halo Seal Flat Package. This device is a non-resorbable and non-sterile, occlusive wound dressin |
| 00850010608211 | Halo Vent Combo IFAK with Pad. This device is a non-resorbable and non-sterile, occlusive wound |
Trademark Results [Halo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HALO 98550340 not registered Live/Pending |
SYDUCT DIAGNOSTICS INC. 2024-05-14 |
 HALO 98529116 not registered Live/Pending |
WH Products, LLC 2024-05-01 |
 HALO 98473348 not registered Live/Pending |
Ultradent Products, Inc. 2024-03-28 |
 HALO 98454522 not registered Live/Pending |
Halo, Inc. 2024-03-18 |
 HALO 98404978 not registered Live/Pending |
Prophetic, Inc. 2024-02-14 |
 HALO 98398702 not registered Live/Pending |
Halo Water Systems, LLC 2024-02-08 |
 HALO 98381032 not registered Live/Pending |
CenTex Aerospace, Inc. 2024-01-29 |
 HALO 98363520 not registered Live/Pending |
Grace O'Donnell 2024-01-18 |
 HALO 98342492 not registered Live/Pending |
REJOICE INTERNATIONAL CORP. 2024-01-04 |
 HALO 98317855 not registered Live/Pending |
American Baitworks Co. 2023-12-16 |
 HALO 98312564 not registered Live/Pending |
Maars Holding B.V. 2023-12-13 |
 HALO 98294381 not registered Live/Pending |
NEXALIN TECHNOLOGY, INC. 2023-12-01 |
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