FDA.reportPublic FDA data

CODA™ Anterior Cervical Plate System

Primary DI
00846468005269
Brand
CODA™ Anterior Cervical Plate System
Company
Pioneer Surgical Technology, Inc.
Model
58-202281001
Catalog number
2022-81-001
Device description
Screw And Plate Tray 4-5
Published
2023-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468005269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468005269008464680052698464680052690846468005269

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(906)226-9909labelrequests@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
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
00840298703685CODA™ Anterior Cervical Plate System58-202230010S2022-30-010S2023-06-28
00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26
00840298701452CODA™ Anterior Cervical Plate System58-102201012S1022-01-012S2023-06-26
00840298701469CODA™ Anterior Cervical Plate System58-102201014S1022-01-014S2023-06-26
00840298701476CODA™ Anterior Cervical Plate System58-102201016S1022-01-016S2023-06-26
00840298701490CODA™ Anterior Cervical Plate System58-102201020S1022-01-020S2023-06-26
00840298701506CODA™ Anterior Cervical Plate System58-102201022S1022-01-022S2023-06-26
00840298701520CODA™ Anterior Cervical Plate System58-102201026S1022-01-026S2023-06-26
00840298701537CODA™ Anterior Cervical Plate System58-102201028S1022-01-028S2023-06-26
00840298701544CODA™ Anterior Cervical Plate System58-102201030S1022-01-030S2023-06-26
00840298701568CODA™ Anterior Cervical Plate System58-102202026S1022-02-026S2023-06-26
00840298701582CODA™ Anterior Cervical Plate System58-102202030S1022-02-030S2023-06-26
00840298701599CODA™ Anterior Cervical Plate System58-102202032S1022-02-032S2023-06-26
00840298701605CODA™ Anterior Cervical Plate System58-102202034S1022-02-034S2023-06-26
00840298701612CODA™ Anterior Cervical Plate System58-102202036S1022-02-036S2023-06-26
00840298701629CODA™ Anterior Cervical Plate System58-102202038S1022-02-038S2023-06-26
00840298701636CODA™ Anterior Cervical Plate System58-102202040S1022-02-040S2023-06-26
00840298701643CODA™ Anterior Cervical Plate System58-102202042S1022-02-042S2023-06-26
00840298701650CODA™ Anterior Cervical Plate System58-102202044S1022-02-044S2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093746ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-22
00642356005645SteriBestMastel Surgical Inc.LRP2026-07-22
00840311264032Cortera Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-07-20
10198956493353CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956501836CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956514683CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956516762CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956518896CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956519589CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956528093CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956529182CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532502CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532779CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532786CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533516CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533752CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956535091CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956493612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956501973CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956526181CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956530935CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956531925CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
03661219527046DELACROIX-CHEVALIERLANDANGERLRP2026-07-12
10198956392977CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956449992CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956482401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518438CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09