FDA.reportPublic FDA data

SURGYCO

Primary DI
00850053289132
Brand
SURGYCO
Company
Surgyco LLC
Model
ST001050
Device description
STAPLE REMOVAL KIT.
Published
2023-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10850053289139PrimaryGS10
00850053289132Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085005328913910850053289139
00850053289132008500532891328500532891320850053289132

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118768538
Device count
50
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
true
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
10850074089060Surgyco010-VPSB21G22025-12-23
10850074089077Surgyco010-VPSB23G22025-12-23
10850074089084Surgyco010-VPSB25G22025-12-23
10850074089091Surgyco010-VPB23G22025-12-23
10850074089107Surgyco010-VPN01102025-12-23
10850074089114Surgyco010-VPN01202025-12-23
20850074089067Surgyco010-VPSB21G22025-12-23
20850074089074Surgyco010-VPSB23G22025-12-23
20850074089081Surgyco010-VPSB25G22025-12-23
20850074089098Surgyco010-VPB23G22025-12-23
20850074089104Surgyco010-VPN01102025-12-23
20850074089111Surgyco010-VPN01202025-12-23
10850053289672SurgycoSEN102302025-12-11
20850053289679SurgycoSEN102302025-12-11
10850074089053ClinicoLab010-16622025-09-10
10850053289870SURGYCOSSNG00102025-07-11
10850053289887SURGYCOSSNG00152025-07-11
10850053289894SURGYCOSSNG00202025-07-11
10850074089015JDL Sensitive010-12502025-07-11
10850074089022JDL Sensitive010-12602025-07-11

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