FDA.reportPublic FDA data

Halo

Primary DI
00862213000471
Brand
Halo
Company
Medical Devices, Inc.
Model
US 1216-10006
Catalog number
US 1216-10006
Device 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 5.5" x 7.5".
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
00862213000471PackageGS1200In Commercial Distribution
00862213000464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862213000471008622130004718622130004710862213000471
00862213000464008622130004648622130004640862213000464

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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