FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040171561
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703408
Catalog number
5703408
Device description
Suture Removal Kit w/ PVP
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MCZSuture removal kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCZSuture Removal KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040171568PrimaryGS10
00304040171561Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404017156810304040171568
00304040171561003040401715613040401715610304040171561

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
50
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
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
50198956326871CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-16
50198956228991CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-02-09
20809160508470Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.MCZ2026-01-09
20809160507602Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.MCZ2026-01-06
10849233014296Busse Hospital DisposablesROBERT BUSSE & CO., INC.MCZ2025-12-29
00850063139458Neil Medical Group Neil Medical GroupMCZ2025-12-08
00850063139465Neil Medical Group Neil Medical GroupMCZ2025-12-08
50198956254778CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-12-02
50198956260038CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-13
50198956160437CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-08-28
20809160486228Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.MCZ2025-07-16
50198956112481CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-07-09
05010058185784InstrapacROBINSON HEALTHCARE LIMITEDMCZ2025-06-25
05010058178458InstrapacROBINSON HEALTHCARE LIMITEDMCZ2025-06-23
50198956057928CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-06-05
50628725005374SUTURE REMOVAL KITCanadian Hospital Specialties LimitedMCZ2025-06-02
10661392000152LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392000169LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392000916LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001739LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001760LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001777LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001784LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001821LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001845LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001869LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001890LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001913LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001999LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392002002LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16