FDA.reportPublic FDA data

EAGLE LABS, LLC

Matched from indexed company URL: Eagle Labs

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20276192027619EAGLE LABS, LLC1N2026-01-01815 Vikings Pkwy Ste 160 Saint Paul MN US 55121

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810090011295N/A - "Small plastic drape, 16""x16"" (41cm x 41cm), with adhesive aperture"909-481-0011eaglelabs@eaglelabs.com
00810090011431N/A - "Small plastic drape, 16"" x 16"" (41cm x 41cm), with adhesive incise"909-481-0011eaglelabs@eaglelabs.com
00810090011448N/A - "Medium plastic drape, 48"" x 50"" (122cm x 127cm), with adhesive incise"909-481-0011eaglelabs@eaglelabs.com
00810090011479N/A - "Medium plastic drape, 48"" x 51"" (122cm x 130cm), with adhesive incise and fluid collection"909-481-0011eaglelabs@eaglelabs.com
00810090011615N/A - "Medium plastic drape, 50"" x 32"" (127cm x 81cm), with adhesive aperture"909-481-0011eaglelabs@eaglelabs.com
00810090012605N/A - "Refractive Drape, 16"" x 10.7"" (41cm x 27cm), with split aperture"909-481-0011eaglelabs@eaglelabs.com
00810090013305N/A - PVA Eye Spears - 5 ea909-481-0011eaglelabs@eaglelabs.com
00810090014166N/A - LASIK Shield, 7mm diameter, 5mm edge909-481-0011eaglelabs@eaglelabs.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
348611840071920K921031EDGE MEDICAL DISPENSING PINLHI1992-10-19
348611086391177K162233Kurin Blood Culture Collection SetJKA2016-12-23
348611068434998K141317ZIP MIS INTERSPINOUS FUSION SYSTEMPEK2014-11-17
348611227634050K140715ZIP MIS INTERSPINOUS FUSION SYSTEMPEK2014-04-17
348611543132212K133967INTERBODY CAGE SYSTEMMAX2014-01-31
348611373993827K133091ZIP MIS INTERSPINOUS FUSION SYSTEMPEK2013-11-27
348611346783177K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIKZE2011-07-27
348612010917678K111484DISCOVERYODP2011-09-12
348611280436141K060089TULIP DISPOSABLE CANNULASQPB2006-04-27
348611077026883
348611148334819
348611200132802
348611488055450
348611045041406
348611148244074
348611392408205
348611471284933
348611887075170
348611974552613

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PEK32014-11-17
JKA12016-12-23
MAX12014-01-31
ODP12011-09-12
KZE12011-07-27
QPB12006-04-27
LHI11992-10-19

NDC#

GUDID#