Uni FB PE-insert

GUDID 04048844030131

implantcast GmbH

Unicondylar knee insert
Primary Device ID04048844030131
NIH Device Record Keyb8af38da-50c7-40b5-ac01-1ff20e83fc69
Commercial Distribution StatusIn Commercial Distribution
Brand NameUni FB PE-insert
Version Model Number40100209
Company DUNS324369826
Company Nameimplantcast GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS104048844030131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-20
Device Publish Date2021-01-12

On-Brand Devices [Uni FB PE-insert]

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0404884448023340100412
0404884448022640100314
0404884448021940100312
0404884448020240100214
0404884448019640100212
0404884448018940100114
0404884448017240100112
0404884448016540101014
0404884448015840101012
0404884448014140101011
0404884448013440101010
0404884448012740101009
0404884448011040101008
0404884403023040100411
0404884403022340100410
0404884403021640100409
0404884403020940100408
0404884403019340100311
0404884403018640100310
0404884403017940100309
0404884403016240100308
0404884403015540100211
0404884403014840100210
0404884403013140100209
0404884403012440100208
0404884403011740100111
0404884403010040100110
0404884403009440100109
0404884403008740100108

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