HTR-PEKK

GUDID 00810023922667

OXFORD PERFORMANCE MATERIALS, INC.

Cranial bone prosthesis, custom-made
Primary Device ID00810023922667
NIH Device Record Keyff72f267-ce5e-4e1b-bd7b-9c0d87dae519
Commercial Distribution StatusIn Commercial Distribution
Brand NameHTR-PEKK
Version Model NumberPK622687
Company DUNS962301359
Company NameOXFORD PERFORMANCE MATERIALS, INC.
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 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
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100810023922667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810023922667]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [HTR-PEKK]

00810042037670PK621713
00810042037663PK621507
00810042037618PK621689-A
00810042037601PK621671-A
00810042037595PK621693-A
00810042037588PK621702
00810042037502PK621440
00810042037496PK621663
00810042037489PK621676
00810042037472PK621677
00810042037465PK621675
00810042037458PK621339
00810042037441PK621649
00810042037427PK621643
00810042037410PK621665
00810042037403PK621652
00810042037397PK621647-A
00810042037380PK621672
00810042037373PK621625
00810042037366PK621656
00810042037359PK621668
00810042037342PK621646-A
00810042037335PK621624-A
00810042037328PK621624
00810042037311PK621653
00810042037304PK621644
00810042037281PK621596
00810042037274PK621641
00810042037267PK621642
00810042037243PK621603
00810042037236PK621615
00810042037229PK621613
00810042037212PK621582
00810042037205PK621626
00810042037175PK621524
00810042037151PK621602
00810042037137PK621563-A
00810042037120PK621604
00810042037113PK621609
00810042037106PK621565-B
00810042037090PK621593
00810042037083PK621581
00810042037076PK621584
00810042037069PK621592
00810042037052PK621590
00810042037045PK621583
00810042037038PK621530
00810042037007PK621402
00810042036994PK621578
00810042036987PK621555-A

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.