POPE VENT TUBE

GUDID 00844505004282

POPE VENT TUBE 1.14MM ID SILICONE PAIR 10 PACK

Grace Medical, Inc.

Tympanostomy tube
Primary Device ID00844505004282
NIH Device Record Keyf5e563a6-6f49-45f5-bf29-672d735b2e51
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOPE VENT TUBE
Version Model Number510-162
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505004282 [Primary]
GS110844505004289 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTUBE, TYMPANOSTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-18
Device Publish Date2016-02-18

On-Brand Devices [POPE VENT TUBE]

00844505008525POPE BEVEL GROMMET VENT TUBE 1.14mm ID POLYETHYLENE, 30 PACK
00844505008518POPE BEVEL GROMMET VENT TUBE 1.14mm ID POLYETHYLENE 5 PACK
00844505004282POPE VENT TUBE 1.14MM ID SILICONE PAIR 10 PACK
00844505004275POPE VENT TUBE 1.14MM ID SILICONE 5 PACK
00844505003186POPE VENT TUBE 1.14MM ID PC SILICONE 5 PACK
10844505014370POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 60 PACK
10844505014363POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK
10844505014356POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
10844505014349POPE VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK

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