FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040000045
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1125822
Catalog number
1125822
Device description
Suture Removal Kit
Published
2020-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10304040000042PrimaryGS10
00304040000045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404000004210304040000042
00304040000045003040400000453040400000450304040000045

GMDN Terms#

Term, Definition table
TermDefinition
Suture removal kitA collection of various sterile instruments, dressings, and pharmaceuticals designed to remove sutures from a patient. It typically includes a disinfectant, scissors, forceps, gauze and bandages. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
012430880
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956404304CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-04-15
10704411018834AMSure ® SUTURE REMOVAL KITAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10704411018841AMSure ® Suture Removal KitAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10704411018858AMSure ® Suture Removal KitAMSINO INTERNATIONAL, INC.MCZ2026-04-03
10198956291362CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-26
10198956326873CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-16
10198956228993CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-02-09
10198956254770CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-12-02
10198956241046CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-19
10198956260030CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-13
10198956160439CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-08-28
10198956112483CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-07-09
10198956057920CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-06-05
10198956053960CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-05-16
10198459280498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459280566Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459280573Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10198459281778Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2025-03-09
10197106916186CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-02-17
10197106818459CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-12-13
10197106828960CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-11-22
10198459182730Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-11-17
10197106833131CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-11-13
10198459137402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-11-03
10198459120886Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-20
10198459145063Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-13
10198459137396Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-10-06
10197106752173CARDINAL HEALTHCardinal Health 200, LLCMCZ2024-09-17
10198459090202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-09-08
10198459092350Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2024-09-08