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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 14 of 230
DeviceModel / ReferenceRegistriesClassStatus
Nytrile X200 PF Nitrile 1125660
FDA UDI
Class IActive
Henry Schein 5703800
FDA UDI
Class IIActive
Henry Schein 5703092
FDA UDI
Class IIActive
Henry Schein 9011042
FDA UDI
Class IIActive
Essentials 5702554
FDA UDI
Class IIActive
Henry Schein 1007016
FDA UDI
Class IActive
Henry Schein 1002524
FDA UDI
Class IActive
Henry Schein 2020208
FDA UDI
Class IActive
Henry Schein 9004403
FDA UDI
Class IActive
Henry Schein 5701011
FDA UDI
Class IActive
Henry Schein 1006693
FDA UDI
Class IActive
Henry Schein 1063327
FDA UDI
Class IActive
Henry Schein 9004708
FDA UDI
Class IActive
Henry Schein 1049206
FDA UDI
Class IActive
Henry Schein 5703467
FDA UDI
Class IActive
Henry Schein 1010711
FDA UDI
Class IIActive
Henry Schein 5701383
FDA UDI
Class IActive
Henry Schein 5703031
FDA UDI
Class IIActive
Henry Schein 1018154
FDA UDI
Class IActive
Henry Schein 1010690
FDA UDI
Class IActive
Henry Schein 1007869
FDA UDI
Class IActive
Henry Schein 1125154
FDA UDI
Class IActive
Henry Schein 9007287
FDA UDI
Class IActive
Henry Schein 1125284
FDA UDI
Class IActive
Henry Schein 1127182
FDA UDI
Class IActive
Henry Schein Maxima 1126564
FDA UDI
Class IActive
Henry Schein 1127054
FDA UDI
Class IActive
Criterion 5703277
FDA UDI
Class IIActive
Henry Schein 9005025
FDA UDI
Class IActive
Henry Schein 1125847
FDA UDI
Class IIActive
Henry Schein 9011717
FDA UDI
Class IIActive
Henry Schein 5701229
FDA UDI
Class IActive
Henry Schein 5700018
FDA UDI
Class IActive
Henry Schein Maxima 1126582
FDA UDI
Class IActive
Henry Schein 9011580
FDA UDI
Class IIActive
Zirlux 9010751
FDA UDI
Class IIActive
Henry Schein 5701504
FDA UDI
Class IIActive
Henry Schein 1000028
FDA UDI
Class IActive
Henry Schein 1125465
FDA UDI
Class IActive
Henry Schein 9009708
FDA UDI
Class IIActive
Henry Schein 9004905
FDA UDI
Class IActive
Henry Schein 9007611
FDA UDI
Class IActive
Henry Schein 9004856
FDA UDI
Class IIActive
Henry Schein 5701282
FDA UDI
Class IActive
Henry Schein 9007851
FDA UDI
Class IActive
Henry Schein 1125905
FDA UDI
Class IIActive
Henry Schein 9012157
FDA UDI
Class IIActive
Maxicide 28 day 1026003
FDA UDI
Class IIActive
Henry Schein 9011082
FDA UDI
Class IIActive
ZCAD TempEsthetic 9007850
FDA UDI
Class IActive

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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.