RELIEVA SPINPLUS NAV RSP0516MFSN

GUDID 20705031241005

RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 5X16MM, 3 GUIDE KIT

ACCLARENT, INC.

Nasal/paranasal balloon catheter
Primary Device ID20705031241005
NIH Device Record Key272c61ba-2c75-41d7-be90-3a3c2ae879ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameRELIEVA SPINPLUS NAV
Version Model NumberRSP0516MFSN
Catalog NumberRSP0516MFSN
Company DUNS361092450
Company NameACCLARENT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(650)687-5888
Emailxxx@xxx.xxx

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031241008 [Primary]
GS120705031241005 [Package]
Contains: 10705031241008
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRCINSTRUMENT, ENT MANUAL SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-22
Device Publish Date2018-02-09

On-Brand Devices [RELIEVA SPINPLUS NAV]

20705031245430RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT - 1PK
20705031245423RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 5X16MM, 3 GUIDE KIT - 1PK
20705031241012RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
20705031241005RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 5X16MM, 3 GUIDE KIT

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