FDA.reportPublic FDA data

Tools-INS

Primary DI
00842188127625
Brand
Tools-INS
Company
Trimed, INC.
Model
RMVIMN-3.0/3.6
Catalog number
RMVIMN-3.0/3.6
Device description
Removal Tool, IM Nail 3.0/3.6mm
Published
2023-09-28
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
00842188127625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188127625008421881276258421881276250842188127625

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, single-useA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
00842188119712Torx Smooth PegSPEG1.8-14SPEG1.8-142019-05-07
00842188119729Torx Smooth PegSPEG1.8-16SPEG1.8-162019-05-07
00842188119736Torx Smooth PegSPEG1.8-18SPEG1.8-182019-05-07
00842188119743Torx Smooth PegSPEG1.8-20SPEG1.8-202019-05-07
00842188119750Torx Smooth PegSPEG1.8-22SPEG1.8-222019-05-07
00842188100000Pin PlatesDUP3DUP32016-09-07
00842188100017Pin PlatesDUP5DUP52016-09-07
00842188100024Pin PlatesDUP7DUP72016-09-07
00842188100031Peg PlatesUPG-5UPG-52016-09-07
00842188100048Peg PlatesUPG-7UPG-72016-09-07
00842188100055Pin PlatesRCP3RCP32016-09-07
00842188100062Pin PlatesRCP5RCP52016-09-07
00842188100079Pin PlatesRCP7RCP72016-09-07
00842188100086Peg PlatesRPGL-7RPGL-72016-09-07
00842188100093Peg PlatesRPGR-7RPGR-72016-09-07
00842188100109Peg PlatesRPGL-10RPGL-102016-09-07
00842188100116Peg PlatesRPGR-10RPGR-102016-09-07
00842188100727Fusion CupsFC07FC072016-09-07
00842188100734Fusion CupsFC10FC102016-09-07
00842188100741Fusion CupsLFC10LFC102016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
B0842003000000Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000010Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000020Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000030Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000100Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000110Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000120Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000130Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000200Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000210Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000220Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000230Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000300Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000310Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000320Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000330Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000400Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000410Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000420Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000430Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000500Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000510Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000520Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000530Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000600Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000610Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000620Keos Lumbar InstrumentKEOSLXH2023-02-10