FDA.reportPublic FDA data

DIAMOND

Primary DI
00840916162122
Brand
DIAMOND
Company
SPINAL ELEMENTS
Model
10043
Device description
DIAMOND 4.3MM SCREW CADDY
Published
2022-03-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916162122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916162122008409161621228409161621220840916162122

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

Regulatory Flags#

DUNS number
004022104
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916162115DIAMOND100402022-03-03
00840916162139DIAMOND100472022-03-03
00840916142926ZEUS-O101122021-01-11
00840916143008ZEUS-O109972021-01-11
00840916160135SPARTAN103132020-12-07
00840916156947ZEUS-O105002020-05-11
00840916117603SLPSS82192017-08-10
00840916149840SAVANNAH91052020-04-16
00840916150143SAVANNAH82712020-04-16
00840916150150SAVANNAH90012020-04-16
00840916150167SAVANNAH90022020-04-16
00840916150174SAVANNAH90042020-04-16
00840916150211SAVANNAH90502020-04-16
00840916150228SAVANNAH90902020-04-16
00840916115555SAMSON135142017-08-01
00840916115562SAMSON135152017-08-01
00840916115579SAMSON135162017-08-01
00840916115586SAMSON135172017-08-01
00840916115593SAMSON135182017-08-01
00840916115609SAMSON135192017-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286306CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956423633CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956461048CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956498433CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956504554CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956512023CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956517363CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956519299CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956530713CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956536784CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956538801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956539594CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956541184CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956542723CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956543959CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956544161CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956544857CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956545663CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956545731CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956546615CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956548688CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956548947CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956550537CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956551671CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956552050CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956554221CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956556584CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956557536CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956558113CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26
10198956559981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-08-26