FDA.reportPublic FDA data

General Instruments

Primary DI
00841132150573
Brand
General Instruments
Company
ORTHOPEDIATRICS CORP.
Model
03-0904-0318
Catalog number
03-0904-0318
Device description
Seat, Split
Published
2020-06-19
Public version status
New
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
JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEBTable, Surgical With Orthopedic Accessories, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132150573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132150573008411321505738411321505730841132150573

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379bsmith@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13
00841132199312OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6014-S00-1200-6014-S2026-05-13
00841132199329OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6015-S00-1200-6015-S2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536822543Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822550Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822567Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822574Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822581Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822598Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822604Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822611Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822628Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822635Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822642Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
04251732800383X-Ray Top Seat section PST 500Jörg & Sohn GmbHJEB2026-05-18
04251732800406X-Ray Top Back section PST 500 UJörg & Sohn GmbHJEB2026-05-18
04251732800413Cart for X-Ray TopsJörg & Sohn GmbHJEB2026-05-18
04251732800420Pad leg section light high H GJörg & Sohn GmbHJEB2026-05-18
04251732800437Clamshell Armboard PadJörg & Sohn GmbHJEB2026-05-18
00190776418670MillenniumAvalign Technologies, Inc.JEB2026-04-09
04251732800338X-Ray Top Head sectionJörg & Sohn GmbHJEB2025-06-26
04251732800345X-Ray Top Back section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800352X-Ray Top Seat section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800369X-Ray Top Universal sectionJörg & Sohn GmbHJEB2025-06-26
04251732800376X-Ray Top Leg section one partJörg & Sohn GmbHJEB2025-06-26
G611BIO110210Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110220Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110230Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110240Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024B0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024C0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110310Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110320Alliant BiotechMEDISURGE LLCJEB2024-08-16