FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
40841767199846
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
10039
Device description
TOURNIQUET R&B 3/4X12
Published
2023-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAXTOURNIQUET, NONPNEUMATIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767199848PackageGS11000In Commercial Distribution
40841767199846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767199848008417671998488417671998480841767199848
4084176719984640841767199846

GMDN Terms#

Term, Definition table
TermDefinition
Tourniquet cuff bandage, non-latexA sterile strip or roll of non-latex containing material that is applied around an extremity (arm or leg) before the fitting of a tourniquet cuff on top of it. This device is used to protect the patient's skin from wrinkling, pinching or shearing and to protect the tourniquet cuff from becoming soiled with blood and other fluids from the operative site. It would typically be folded back over the exposed edges of the cuff to provide maximum protection. 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
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

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Primary DI, Brand, Company table
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