ACCLARENT SE INFLATION DEVICE SEID

GUDID 30705031230860

ACCLARENT SE INFLATION DEVICE

ACCLARENT, INC.

Catheter/overtube balloon inflator, single-use
Primary Device ID30705031230860
NIH Device Record Key2cf2bbaf-7aad-4f1f-9a26-ad28e4a1f6d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameACCLARENT SE INFLATION DEVICE
Version Model NumberSEID
Catalog NumberSEID
Company DUNS361092450
Company NameACCLARENT, 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 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
Emailxx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110705031230866 [Primary]
GS130705031230860 [Package]
Contains: 10705031230866
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 Date2020-05-06
Device Publish Date2016-10-01

On-Brand Devices [ACCLARENT SE INFLATION DEVICE]

20705031230863ACCLARENT SE INFLATION DEVICE, 1 PK
30705031230860ACCLARENT SE INFLATION DEVICE

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