KyphPak® First Fracture Tray

GUDID 00643169671768

KIT KPX153AB-CDS 15/3 FF ADV WITH CDS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit
Primary Device ID00643169671768
NIH Device Record Key880c7792-1ab1-4f7a-98ae-a9efe1024d91
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyphPak® First Fracture Tray
Version Model NumberKPX153AB-CDS
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (at max 25°C/77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place (at max 25°C/77°F)

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169671768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

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 Date2016-04-03

On-Brand Devices [KyphPak® First Fracture Tray]

00643169671843KIT KPX203PB-CDS 20/3 FF 1-STEP WITH CDS
00643169671829KIT KPX203AB-CDS 20/3 FF ADV WITH CDS
00643169671805KIT KPX203RB-CDS 20/3 FF OTEO WITH CDS
00643169671782KIT KPX153PB-CDS 15/3 FF 1-STEP WITH CDS
00643169671768KIT KPX153AB-CDS 15/3 FF ADV WITH CDS
00643169671744KIT KPX153RB-CDS 15/3 FF OSTEO WITH CDS
00643169671720KIT KPX103PB-CDS 10/3 FF 1-STEP WITH CDS
00643169671706KIT KPX103AB-CDS 10/3 FF ADV WITH CDS
00643169671683KIT KPX103RB-CDS 10/3 FF OSTEO WITH CDS
00643169671669KIT KEX202EB-CDS- 20/2 FF WITH CDS
00643169671645KIT KEX152EB-CDS- 15/2 FF WITH CDS
00643169671621KIT KEX102EB-CDS- 10/2 FF WITH CDS

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.