FDA.reportPublic FDA data

Halo

Primary DI
00850010608259
Brand
Halo
Company
Medical Devices, Inc.
Model
US 1216-10010
Catalog number
US 1216-10010
Device description
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.
Published
2023-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010608259PackageGS1200In Commercial Distribution
00850010608242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010608259008500106082598500106082590850010608259
00850010608242008500106082428500106082420850010608242

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Temperature-30 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.828.4681info@medicaldevicesinc.com

Regulatory Flags#

DUNS number
101571834
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010608228HaloUK 1216-10008UK 1216-100082026-02-20
00850010608525HaloUK 1216-10020UK 1216-100202026-02-20
00850010608235HaloUK 1216-10008UK 1216-100082026-02-20
00850010608532HaloUK 1216-10020UK 1216-100202026-02-20
00850010608006Halo1216-100001216-100002021-03-02
00850010608020Halo1216-100021216-100022021-03-02
00850010608044Halo1216-100041216-100042021-03-02
00850010608068Halo1216-100101216-100102021-03-02
00850010608129Halo1216-100061216-100062021-03-02
00850010608549HaloUS 1216-10034US 1216-100342025-12-18
00850010608556HaloUS 1216-10034US 1216-100342025-12-18
00850010608327HaloUS 1216-10032US 1216-100322025-01-07
00085001060833HaloUS 1216-10032US 1216-100322025-01-07
00850010608082Halo1216-100201216-100202021-03-02
00850010608105Halo1216-100081216-100082021-03-02
00850010608143Halo1216-100121216-100122021-03-02
00850010608204Halo1216-100301216-100302023-03-08
00850010608341HaloEU 1216-10000EU 1216-100002023-05-31
00850010608365HaloEU 1216-10002EU 1216-100022023-05-31
00850010608389HaloEU 1216-10004EU 1216-100042023-05-31

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Primary DI, Brand, Company table
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00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
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00324357410078Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
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