RICHARDS BUCKET HANDLE 10 MM WELL ID 6 MM DIA 425 MM LONG TITANIUM

GUDID 00821925021556

Replace the portion of the ossicular chain that has lost its function due to disease congenital defect or other pathological process

Gyrus Acmi, Inc.

Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial
Primary Device ID00821925021556
NIH Device Record Key26639beb-aa84-4f29-8e91-0510066ad65e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRICHARDS BUCKET HANDLE 10 MM WELL ID 6 MM DIA 425 MM LONG TITANIUM
Version Model Number70142165
Company DUNS007198742
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx
Phone1(800)262-3540
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS100821925021556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETBProsthesis, Partial Ossicular Replacement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

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00821925041431 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
00821925041448 - InstaClear2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
00821925041455 - InstaClear2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
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