FDA.reportPublic FDA data

OmniTrustTM

Primary DI
50810572006097
Brand
OmniTrustTM
Company
OMNI INTERNATIONAL CORP.
Model
9012-33
Catalog number
9012-33
Device description
Gauze Sponge, Non-Sterile, 3x3, 8 Ply
Published
2019-08-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810572006097PackageGS120In Commercial Distribution
00810572006092PrimaryGS10
10810572006099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081057200609750810572006097
00810572006092008105720060928105720060920810572006092
1081057200609910810572006099

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Width3Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 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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