FDA.reportPublic FDA data

Instrapac

Primary DI
05010058078451
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
7845
Catalog number
7845
Device description
Instrapac Iris Pack X 50
Published
2025-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
05010058178458PackageGS150In Commercial Distribution
05010058078451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058178458050100581784585010058178458
05010058078451050100580784515010058078451

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep out of direct sunlight

Contacts#

Phone, Email table
PhoneEmail
+441909735502ASKVCI@vernacare.com

Regulatory Flags#

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05010058070158Instrapac701570152023-08-08
05010058070172Instrapac7017 Delivery Pack - 18cm/7in Forceps70172020-11-26
05010058070219Instrapac702170212022-08-12
05010058070226Instrapac702270222022-08-12
05010058070233Instrapac702370232022-08-12
05010058070240Instrapac702470242023-08-08
05010058070264Instrapac702670262024-02-28
05010058070318Instrapac703170312022-08-12
05010058070325Instrapac703270322022-08-12
05010058070332Instrapac703370332022-08-12
05010058070349Instrapac703470342022-08-12
05010058070356Instrapac703570352022-08-12
05010058070370Instrapac703770372023-08-08
05010058070424Instrapac704270422023-08-08
05010058070479Instrapac704770472022-08-12
05010058070493Instrapac704970492023-08-08
05010058070530Instrapac705370532022-08-12
05010058070578Instrapac705770572023-08-08
05010058070592Instrapac705970592022-08-12
05010058070615Instrapac706170612023-08-08

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