FDA.reportPublic FDA data

ORDOCK 2 CUPS, DISPOSABLE

Primary DI
B992141010
Brand
ORDOCK 2 CUPS, DISPOSABLE
Company
JB Medical Development, LLC
Model
14-101
Catalog number
14101
Device description
2 STERILE CUPS THAT ATTACH TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE
Published
2021-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
B992141010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-use, sterileA sterile device intended to be used in the operating room (OR) by staff 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 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, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18776036333hsjeck@md3inc.com

Regulatory Flags#

DUNS number
873149871
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
B992141000ORDOCK PLATFORM, RE-USABLE14-100141002021-02-08

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