FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
00841767103487
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
5074
Device description
FN-PT SPLINT FCP 4.5 STER
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
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767103487PackageGS150In Commercial Distribution
10841767103484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767103487008417671034878417671034870841767103487
1084176710348410841767103484

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, single-useA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
10198956566644CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956568280CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956578357CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956581654CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956586178CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956580268CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-22
10198956562271CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956573550CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956584426CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10653160394389MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394419MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394525MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394648MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394761MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394891MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394990MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160395140MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10198956538856CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956539617CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956556744CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956564367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10653160394600MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-08-27
10198956541474CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10198956548701CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10198956557758CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10653160394358MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-08-26
10198956539358CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-18
10198956499348CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-17
10198956538511CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-17
10198956490895CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-07-31