FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040132095
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701979
Catalog number
5701979
Device description
Instrument ID Tape Kit
Published
2020-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LYVLABEL OR TAG, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040132098PrimaryGS10
10304040132095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040132098003040401320983040401320980304040132098
1030404013209510304040132095

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument track identification tapeA non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
8
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B050SL1000021Sterile LabelsTYPENEX MEDICAL LLCLYV2026-03-17
17540277009646PharmaTagsRMAC Surgical, IncLYV2026-03-12
17540277009639PharmaTagsRMAC Surgical, IncLYV2026-03-03
17540277000001PharmaTagsRMAC Surgical, IncLYV2026-02-06
10754027700104PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700111PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700142PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700173PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700265PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700715PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700722PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700739PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700746PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700753PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700777PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700784PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700791PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700807PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700814PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700821PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700838PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700845PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700852PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700869PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700876PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700883PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700890PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700906PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700913PharmaTagsRMAC Surgical, IncLYV2026-02-02
10754027700920PharmaTagsRMAC Surgical, IncLYV2026-02-02