HTR-PEKK

GUDID 00810042037427

OXFORD PERFORMANCE MATERIALS, INC.

Cranial bone prosthesis, custom-made Cranial bone prosthesis, custom-made Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis Custom-made cranial bone prosthesis
Primary Device ID00810042037427
NIH Device Record Key0c9a1fce-5b18-48dd-838d-b740f0240320
Commercial Distribution StatusIn Commercial Distribution
Brand NameHTR-PEKK
Version Model NumberPK621643
Company DUNS962301359
Company NameOXFORD PERFORMANCE MATERIALS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com
Phone904-741-4400
Emailfxjax-orders@biomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810042037427 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


[00810042037427]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-29
Device Publish Date2019-01-17

On-Brand Devices [HTR-PEKK]

00810042031517PK620326
00810042031494PK620320
00810042031401PK620293
00810042031364PK620279
00810042031326PK620284
00810042031272PK620271
00810042031265PK620274
00810042031258PK620253
00810042031241PK620269
00810042031234PK620283
00810042031227PK620092
00810042031210PK620275
00810042031203PK620276
00810042031197PK620255
00810042031173PK620266
00810042031166PK620270
00810042031074PK620254
00810042031036PK620171
00810042030909PK620227
00810042030848PK620219
00810042030817PK620201
00810042030800PK620188
00810042030787PK620200
00810042030732PK620064
00810042030725PK620190
00810042030718PK620170
00810042030695PK620160
00810042030671PK620162
00810042030664PK620133-A
00810042030657PK620159
00810042030640PK620161
00810042030633PK620168
00810042030619PK619947
00810042030602PK620150
00810042030596PK620153
00810042030589PK620157
00810042030572PK620134
00810042030565PK620142
00810042030558PK620141
00810042030398PK620107
00810042030374PK620104
00810042030343PK620085
00810042030299PK620084
00810042030268PK620067
00810042030206PK619900
00810042030183PK620044
00810042030176PK619972
00810042030169PK619930
00810042030145PK620018
00810042030138PK620024

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