FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
00841767107362
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
82040
Device description
LACERATION TRAY
Published
2023-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
00841767107362PackageGS125In Commercial Distribution
10841767107369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767107362008417671073628417671073620841767107362
1084176710736910841767107369

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
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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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