FDA.reportPublic FDA data

ORDOCK CUP, DISPOSABLE

Primary DI
B99214101010
Brand
ORDOCK CUP, DISPOSABLE
Company
JB Medical Development, LLC
Model
14-101-01
Catalog number
1410101
Device description
A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SOLD SINGLY TO ACCOMMODATE HOSPITALS WHO WISH TO BUY IN BULK. HOWEVER TWO CUPS ARE REQUIRED TO BE ATTACHED TO THE PLATFORM WHEN IT IS BEING USED.
Published
2022-01-18
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
B99214101010PrimaryHIBCC0

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
B992151000PREFERX DELIVERY SYSTEM, DISPOSABLE15-100151002021-09-29
B992101000BIO-SAV BONE MILL, DISPOSABLE10-100101002021-05-10
B992141000ORDOCK PLATFORM, RE-USABLE14-100141002021-02-08
B992141010ORDOCK 2 CUPS, DISPOSABLE14-101141012021-02-08

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