FDA.report

OmniTrustTM

Primary DI
50810572006059
Brand
OmniTrustTM
Company
OMNI INTERNATIONAL CORP.
Model
9012-24
Catalog number
9012-24
Device description
Gauze Sponge, Non-Sterile, 2x2, 12 Ply
Published
2019-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50810572006059PackageGS140In Commercial Distribution
00810572006054PrimaryGS10
10810572006051Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5081057200605950810572006059
00810572006054008105720060548105720060540810572006054
1081057200605110810572006051

GMDN Terms

TermDefinition
Woven gauze pad, non-sterileA non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications. This is a single-use device.

Device Sizes

TypeValueUnit
Length2Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(603)471-1499Info@Omnigloves.com

Regulatory Flags

DUNS number
079434709
Device count
200
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50810572002211OmniTrust315-11315-112025-05-15
10810572002220OmniTrust315-12315-122025-05-15
50810572002235OmniTrust315-13315-132025-05-15
50810572002242OmniTrust315-14315-142025-05-15
50810572000439OmniTrust201-225201-2252025-01-31
50810572003485OmniTrust201-120201-1202025-01-31
50810572003539OmniTrust201-125201-1252025-01-31
50810572003546OmniTrush201-220201-2202025-01-31
50810572004550OmniTrust413-00413-002024-07-23
50810572004567OmniTrust413-01413-012024-07-22
50810572004581OmniTrust413-03413-032024-07-22
50810572004574OmniTrust413-02413-022024-07-22
50810572004598OmniTrust413-04413-042024-07-22
50810572004482OmniTrust2155-402155-402024-02-05
50810572004499OmniTrust2155-412155-412024-02-05
50810572004505OmniTrust2155-422155-422024-02-05
50810572004512OmniTrust2155-432155-432024-02-05
50810572004529OmniTrust2155-442155-442024-02-05
50810572004536OmniTrust2155-452155-452024-02-05
50810572004420OmniTrust217-20217-202024-01-22

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