FDA.reportPublic FDA data

Tools - WS3

Primary DI
00842188127984
Brand
Tools - WS3
Company
Trimed, INC.
Model
SBOLT2.4-22
Catalog number
SBOLT2.4-22
Device description
Seating Bolt 2.4, 22mm
Published
2024-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188127984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188127984008421881279848421881279840842188127984

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone-fragment manipulator, single-useA hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the skin and into a craniofacial fracture) and removed after positioning and fixation of the fracture. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188101328Total Wrist Fusion PlatesRFP-STDRFP-STD2016-09-07
00842188101335Total Wrist Fusion PlatesRFP-SHBRFP-SHB2016-09-07
00842188101342Total Wrist Fusion PlatesRFP-STRRFP-STR2016-09-07
00842188105210Cancellous Screw 3.8mmCAB3.8-10CAB3.8-102016-09-07
00842188105227Cancellous Screw 3.8mmCAB3.8-12CAB3.8-122016-09-07
00842188105234Cancellous Screw 3.8mmCAB3.8-14CAB3.8-142016-09-07
00842188105241Cancellous Screw 3.8mmCAB3.8-16CAB3.8-162016-09-07
00842188105258Cancellous Screw 3.8mmCAB3.8-18CAB3.8-182016-09-07
00842188105265Cancellous Screw 3.8mmCAB3.8-20CAB3.8-202016-09-07
00842188105272Cancellous Screw 3.8mmCAB3.8-22CAB3.8-222016-09-07
00842188105289Cancellous Screw 3.8mmCAB3.8-24CAB3.8-242016-09-07
00842188105296Cancellous Screw 3.8mmCAB3.8-26CAB3.8-262016-09-07
00842188105302Cancellous Screw 3.8mmCAB3.8-28CAB3.8-282016-09-07
00842188105319Cancellous Screw 3.8mmCAB3.8-30CAB3.8-302016-09-07
00842188105326Cancellous Screw 3.8mmCAB3.8-32CAB3.8-322016-09-07
00842188105333Cancellous Screw 3.8mmCAB3.8-34CAB3.8-342016-09-07
00842188105340Cancellous Screw 3.8mmCAB3.8-36CAB3.8-362016-09-07
00842188105357Cancellous Screw 3.8mmCAB3.8-38CAB3.8-382016-09-07
00842188105364Cancellous Screw 3.8mmCAB3.8-40CAB3.8-402016-09-07
00842188121739CannCompScrew 2.3mm (SelfDrill)L2327L23272021-01-11

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