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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 8 of 230
DeviceModel / ReferenceRegistriesClassStatus
Henry Schein 1126090
FDA UDI
Class IIActive
Henry Schein 5703149
FDA UDI
Class IActive
Criterion CR Surgeons Glove 1127079
FDA UDI
Class IActive
Zirlux 9010802
FDA UDI
Class IActive
Hseu 5702543
FDA UDI
UActive
Zirlux 9012233
FDA UDI
Class IIActive
Zirlux 9011315
FDA UDI
Class IIActive
Zirlux 901-0343
FDA UDI
Class IIActive
Henry Schein 5702727
FDA UDI
Class IActive
Henry Schein 9001894
FDA UDI
Class IActive
Maxi-Gard 5702295
FDA UDI
Class IActive
Henry Schein 1066167
FDA UDI
Class IActive
Henry Schein 5702212
FDA UDI
Class IActive
Henry Schein Maxima 1125541
FDA UDI
Class IActive
Henry Schein 9011591
FDA UDI
Class IIActive
Henry Schein 1077157
FDA UDI
Class IActive
Henry Schein 5702795
FDA UDI
Class IActive
Henry Schein 9007819
FDA UDI
Class IActive
Henry Schein 9011574
FDA UDI
Class IIActive
Henry Schein 9004094
FDA UDI
Class IIActive
Henry Schein 1005056
FDA UDI
Class IIActive
Henry Schein 1045530
FDA UDI
Class IActive
Henry Schein 9007458
FDA UDI
Class IIActive
Henry Schein 1126072
FDA UDI
Class IIActive
Henry Schein 9011774
FDA UDI
Class IIActive
Henry Schein 9011503
FDA UDI
Class IIActive
Criterion PC Glove PF Latex 1025418
FDA UDI
Class IActive
Henry Schein 1126778
FDA UDI
Class IIActive
Henry Schein 1007810
FDA UDI
Class IActive
Henry Schein 001126286
FDA UDI
Class IActive
Henry Schein 5703540
FDA UDI
Class IActive
Henry Schein 5702809
FDA UDI
Class IIActive
Henry Schein 9004759
FDA UDI
Class IActive
Henry Schein 5702907
FDA UDI
Class IIActive
Henry Schein 5702826
FDA UDI
Class IIActive
Henry Schein 1047595
FDA UDI
Class IActive
Henry Schein 1007737
FDA UDI
Class IActive
Henry Schein 9011473
FDA UDI
Class IIActive
Henry Schein 5702465
FDA UDI
Class IIActive
Zirlux 901-0414
FDA UDI
Class IIActive
Henry Schein 5701881
FDA UDI
Class IIActive
Maxi-Gard 5702296
FDA UDI
Class IActive
Henry Schein 9004769
FDA UDI
Class IActive
Henry Schein 1125086
FDA UDI
Class IActive
Henry Schein 9007669
FDA UDI
Class IActive
Henry Schein 2020309
FDA UDI
Class IActive
Henry Schein 5700756
FDA UDI
Class IActive
Henry Schein 1007090
FDA UDI
Class IActive
Henry Schein 1005685
FDA UDI
Class IActive
Henry Schein 1064528
FDA UDI
Class IIActive

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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.