FDA.reportPublic FDA data

OmniTrustTM

Primary DI
00810572006344
Brand
OmniTrustTM
Company
Omni International Corp.
Model
9071-59
Catalog number
9071-59
Device description
ABD Combine Dressing, Sterile, 5x9
Published
2019-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
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
50810572006349PackageGS120In Commercial Distribution
00810572006344PrimaryGS10
10810572006341Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081057200634950810572006349
00810572006344008105720063448105720063440810572006344
1081057200634110810572006341

GMDN Terms#

Term, Definition table
TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch
Width9Inch

Contacts#

Phone, Email table
PhoneEmail
+1(603)471-1499Info@Omnigloves.com

Regulatory Flags#

DUNS number
079434709
Device count
20
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50810572000095OmniTrustTM50325-1950325-192020-12-11
00810572000045OmniTrustTM80250-2980250-292020-12-16
00810572000397OmniTrustTM9112-319112-312020-12-10
00810572000434OmniTrust201-225201-2252025-01-31
00810572000861OmniTrustTM313-11313-112019-09-06
00810572000878OmniTrustTM313-12313-122019-08-27
00810572000885OmniTrustTM313-13313-132019-08-27
00810572000892OmniTrustTM313-14313-142019-08-27
00810572001127OmniTrustTM113-01113-012019-08-27
00810572001134OmniTrustTM113-02113-022019-08-27
00810572001141OmniTrustTM113-03113-032019-08-27
00810572001158OmniTrustTM113-04113-042019-08-27
00810572001165OmniTrustTM212-20212-202019-08-27
00810572001172OmniTrustTM212-21212-212019-08-27
00810572001189OmniTrustTM212-22212-222019-08-27
00810572001196OmniTrustTM212-23212-232019-08-27
00810572001202OmniTrustTM212-24212-242019-08-27
00810572001271OmniTrustTM312-11312-112019-08-27
00810572001288OmniTrustTM312-12312-122019-08-27
00810572001295OmniTrustTM312-13312-132019-08-27

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Primary DI, Brand, Company table
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