FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
10841767106874
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
85315
Device description
PORT DRESSING CHANGE KIT
Published
2023-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767106877PackageGS130In Commercial Distribution
10841767106874PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767106877008417671068778417671068770841767106877
1084176710687410841767106874

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, non-medicatedA collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
154424043
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841767195717Trinity Sterile, Inc.500502026-08-25
10841767100537Trinity Sterile, Inc.5007M2026-10-06
10841767104696Trinity Sterile, Inc.826042023-07-28
10841767104795Trinity Sterile, Inc.812112023-06-07
10841767104818Trinity Sterile, Inc.812172023-06-07
10841767104825Trinity Sterile, Inc.812282023-06-07
10841767104849Trinity Sterile, Inc.81229A2023-06-07
10841767104962Trinity Sterile, Inc.812482023-06-05
10841767104979Trinity Sterile, Inc.812492023-06-05
10841767104986Trinity Sterile, Inc.812432023-06-07
10841767105143Trinity Sterile, Inc.816552023-04-04
10841767105181Trinity Sterile, Inc.81254B2023-06-05
10841767105211Trinity Sterile, Inc.816512023-03-29
10841767105327Trinity Sterile, Inc.816642023-06-02
10841767105334Trinity Sterile, Inc.813532023-06-05
10841767106614Trinity Sterile, Inc.813452023-06-05
10841767106621Trinity Sterile, Inc.813712023-06-02
10841767106645Trinity Sterile, Inc.814282023-06-02
10841767106652Trinity Sterile, Inc.814322023-04-05
10841767106720Trinity Sterile, Inc.816632023-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160395461MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395713MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395720MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395782MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395805MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395812MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395911MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10198956594739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956596276CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394433MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394457MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394556MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394587MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394662MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394679MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394693MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394907MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395072MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395096MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395102MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395218MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15