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HENRY SCHEIN, INC.

United States·US-MF-000021683

Last updated May 30, 2026

Information

Country
United States
Address
135, Duryea Road, Melville, United States
LinkedIn
—
Facebook
—
Phone
+1(732)918-0770
PRRC Contact
Tracey Alexander
EUDAMED SRN
US-MF-000021683
FDA FEI Number
—
DUNS Number
012430880

Catalogue (11454)

Page 15 of 230
DeviceModel / ReferenceRegistriesClassStatus
Henry Schein 9000671
FDA UDI
Class IActive
Stratosphere 1002052
FDA UDI
Class IIActive
Henry Schein 1000583
FDA UDI
Class IActive
Henry Schein 1064267
FDA UDI
Class IActive
Henry Schein 1000239
FDA UDI
Class IActive
Zirlux 9010363
FDA UDI
Class IActive
Criterion N200 PF Nitrile Case 1125837
FDA UDI
Class IActive
Henry Schein 9007076
FDA UDI
Class IActive
Henry Schein 5701570
FDA UDI
Class IIActive
Henry Schein 9004744
FDA UDI
Class IActive
Henry Schein 1019055
FDA UDI
Class IActive
Henry Schein 5703005
FDA UDI
Class IIActive
Henry Schein 5701469
FDA UDI
Class IActive
Henry Schein 1018291
FDA UDI
Class IActive
Henry Schein 5701650
FDA UDI
Class IIActive
Henry Schein 9007235
FDA UDI
Class IActive
Henry Schein 5700606
FDA UDI
Class IActive
Henry Schein 9011200
FDA UDI
Class IIActive
Henry Schein 5701624
FDA UDI
Class IIActive
Henry Schein 9004810
FDA UDI
Class IActive
Henry Schein 9011637
FDA UDI
Class IIActive
Henry Schein 1067638
FDA UDI
Class IActive
Zirlux 9012365
FDA UDI
Class IIActive
Henry Schein 5700743
FDA UDI
Class IActive
Henry Schein 5701691
FDA UDI
Class IIActive
Henry Schein 5700642
FDA UDI
Class IActive
Henry Schein 5701231
FDA UDI
Class IActive
Henry Schein 1000682
FDA UDI
Class IActive
Henry Schein 1006640
FDA UDI
Class IActive
Henry Schein 1125933
FDA UDI
Class IIActive
Henry Schein 2020072
FDA UDI
Class IActive
Henry Schein 9011525
FDA UDI
Class IIActive
Henry Schein 1005721
FDA UDI
Class IIActive
Henry Schein 9004767
FDA UDI
Class IActive
Henry Schein 9007921
FDA UDI
Class IActive
Henry Schein 9012201
FDA UDI
Class IIActive
Criterion CR Chloroprene Glove 1126858
FDA UDI
Class IActive
Henry Schein 5703042
FDA UDI
Class IIActive
Zirlux 9012354
FDA UDI
Class IIActive
Henry Schein 1011621
FDA UDI
Class IActive
Henry Schein 5750454
FDA UDI
Class IIActive
Henry Schein 5702579
FDA UDI
Class IIActive
Nytrile X200 PF Nitrile 1125660
FDA UDI
Class IActive
Henry Schein 1126239
FDA UDI
Class IActive
Zirlux 901-0576
FDA UDI
Class IIActive
Henry Schein 5700998
FDA UDI
Class IActive
Henry Schein Maxima 1126645
FDA UDI
Class IActive
Henry Schein 1002302
FDA UDI
Class IActive
Henry Schein 5701217
FDA UDI
Class IActive
Henry Schein 1125141
FDA UDI
Class IActive

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Nov 10, 2011Z-0390-2012—terminated

The specific lots of Maxcem Elite Refill Kit appear not to be authentic.

Jun 27, 2003Z-1046-03—terminated

FDA's analysis revealed defects (holes) in the latex gloves.

Jun 27, 2003Z-1045-03—terminated

FDA's analysis revealed defects (holes) in the latex gloves.