FDA.report

Trinity Sterile, Inc.

Primary DI
00841767103302
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
5016
Device description
WIRE CUT SCIS ANG 4 3/4
Published
2023-06-27
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

Related Records

Product Codes

CodeName
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841767103302PackageGS150In Commercial Distribution
10841767103309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767103302008417671033028417671033020841767103302
1084176710330910841767103309

GMDN Terms

TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.

Sterilization Methods

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 DIBrandModelCatalogPublished
50649111345775Trinity Sterile, Inc.94-19242024-12-16
50649111492691Trinity Sterile, Inc.96-3566A2024-12-16
50649111449701Trinity Sterile, Inc.96-36152024-12-16
10841767198275Trinity Sterile, Inc.T97-7052025-01-06
10841767101084Trinity Sterile, Inc.T97-7482024-10-30
10841767101091Trinity Sterile, Inc.T97-7512024-10-30
10841767198282Trinity Sterile, Inc.T97-7102024-10-30
10841767198312Trinity Sterile, Inc.T97-7422024-10-30
10841767198374Trinity Sterile, Inc.T97-7712024-10-30
10841767198381Trinity Sterile, Inc.T97-7722024-10-30
10841767198398Trinity Sterile, Inc.T97-7752024-10-30
10841767198404Trinity Sterile, Inc.T97-7762024-10-30
10841767198411Trinity Sterile, Inc.T97-7772024-10-30
10841767198428Trinity Sterile, Inc.T97-7782024-10-30
10841767101237Trinity Sterile, Inc.T98-8012024-10-28
10841767101114Trinity Sterile, Inc.T97-7932024-10-25
10841767198442Trinity Sterile, Inc.T97-7912024-10-25
10841767198466Trinity Sterile, Inc.T97-8102024-10-25
10841767198473Trinity Sterile, Inc.T97-8322024-10-25
10841767198497Trinity Sterile, Inc.T97-8472024-10-25

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