FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
00841767102992
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
20388
Device description
GENERAL PURPOSE INSTR TRAY
Published
2023-09-05
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
KDDKit, surgical instrument, disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767102992PackageGS150In Commercial Distribution
10841767102999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767102992008417671029928417671029920841767102992
1084176710299910841767102999

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154424043
Device count
1
DM exempt
true
Premarket exempt
true
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
10841767195717Trinity Sterile, Inc.500502026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756400442DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-21
00749756394666DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756397193DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401708DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00749756401715DeRoyalDEROYAL INDUSTRIES, INC.KDD2026-09-18
00889795154668Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154675Primal OCDParagon 28, Inc.KDD2026-07-14
00889795154682Primal OCDParagon 28, Inc.KDD2026-07-14
20653405990328Infinity™Conmed CorporationKDD2026-06-10
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327277680Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278243Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10885380194108Aero-MedAERO-MED, LLCKDD2022-12-15