FDA.reportPublic FDA data

ORDOCK PLATFORM, RE-USABLE

Primary DI
B992141000
Brand
ORDOCK PLATFORM, RE-USABLE
Company
JB Medical Development, LLC
Model
14-100
Catalog number
14100
Device description
PLATFORM (RE-USABLE) TO WHICH 2 ORDOCK CUPS (Not INCLUDED) ARE ATTACHED TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE, NEEDS TO BE STERILIZED PRIOR TO USE (SEE INSTRUCTIONS FOR AUTOCLAVE)
Published
2021-02-08
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
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
B992141000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, reusableA device intended to be used to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, telescopic tube, magnetic mat), may be attached to a surgical drape, and may be used for subsequent sterilization of the instrument(s); it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8776036333hsjeck@md3inc.com

Regulatory Flags#

DUNS number
873149871
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
B99214101010ORDOCK CUP, DISPOSABLE14-101-0114101012022-01-18
B992151000PREFERX DELIVERY SYSTEM, DISPOSABLE15-100151002021-09-29
B992101000BIO-SAV BONE MILL, DISPOSABLE10-100101002021-05-10
B992141010ORDOCK 2 CUPS, DISPOSABLE14-101141012021-02-08

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