FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
10841767105167
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
82029
Device description
LACERATION TRAY
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
PKDLaceration tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKDLaceration TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767105160PackageGS110In Commercial Distribution
10841767105167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767105160008417671051608417671051600841767105160
1084176710516710841767105167

GMDN Terms#

Term, Definition table
TermDefinition
Wound closure set, topicalA collection of sterile devices used to topically close easily-approximated skin edges of wounds. It typically includes a pressure-sensitive adhesive tape or mesh and a liquid adhesive, each contained within a dispensing applicator. The tape/mesh is first applied to temporarily approximate the skin edges followed by application of the liquid adhesive, over the tape/mesh, which polymerizes to affect wound closure. This set may be used to treat surgical incisions, simple lacerations, and may also be used in conjunction with deep dermal stitches. 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
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
10841767106737Trinity Sterile, Inc.816662023-06-02
10841767106744Trinity Sterile, Inc.816672023-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956193611CARDINAL HEALTHCardinal Health 200, LLCPKD2026-02-17
10198956269521CARDINAL HEALTHCardinal Health 200, LLCPKD2026-01-15
10198956272422CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-19
10198956258549CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-11
10198956274327CARDINAL HEALTHCardinal Health 200, LLCPKD2025-12-09
10198956161832CARDINAL HEALTHCardinal Health 200, LLCPKD2025-11-25
10198459475177MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-18
10198459467455MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-11
10198459426209MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-04
10198459437960MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-08-04
10198459350924MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459424427MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459437854MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459440311MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459442155MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-28
10198459432422MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-21
10198459432590MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-21
10198956099371CARDINAL HEALTHCardinal Health 200, LLCPKD2025-07-21
10198459400230MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-07
10198459389337MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-02
10198459391613MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-07-02
10198956104181CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-26
10198459333491MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459369735MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459370199MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459375637MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198459379086MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-06-16
10198956042117CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-11
10198956071797CARDINAL HEALTHCardinal Health 200, LLCPKD2025-06-09
10198459333187MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PKD2025-05-02