FDA.reportPublic FDA data

Instrapac

Primary DI
05010058174047
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
7404
Catalog number
7404
Device description
Instrapac Vaginal Examination/Catheterisation Pack X 20
Published
2025-06-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PVXVaginal Examination Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PVXVaginal Examination TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058174047PackageGS120In Commercial Distribution
05010058074040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058174047050100581740475010058174047
05010058074040050100580740405010058074040

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
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
05010058074026InstrapacROBINSON HEALTHCARE LIMITEDPVX2025-06-23
05010058074040InstrapacROBINSON HEALTHCARE LIMITEDPVX2025-06-23
05010058174023InstrapacROBINSON HEALTHCARE LIMITEDPVX2025-06-23
10197106862445CARDINAL HEALTHCardinal Health 200, LLCPVX2025-01-30
50197106862443CARDINAL HEALTHCardinal Health 200, LLCPVX2025-01-30
10197106819579CARDINAL HEALTHCardinal Health 200, LLCPVX2024-11-20
50197106819577CARDINAL HEALTHCardinal Health 200, LLCPVX2024-11-20
10197106325148CARDINAL HEALTHCardinal Health 200, LLCPVX2023-07-03
50197106325146CARDINAL HEALTHCardinal Health 200, LLCPVX2023-07-03
10197106101674CARDINAL HEALTHCardinal Health 200, LLCPVX2023-03-20
50197106101672CARDINAL HEALTHCardinal Health 200, LLCPVX2023-03-20
H65857032395Henry ScheinHENRY SCHEIN, INC.PVX2022-12-13
H65857032305Henry ScheinHENRY SCHEIN, INC.PVX2022-11-22
H65857032301Henry ScheinHENRY SCHEIN, INC.PVX2022-11-22
10195594890438CARDINAL HEALTHCardinal Health 200, LLCPVX2022-10-21
50195594890436CARDINAL HEALTHCardinal Health 200, LLCPVX2022-10-21
M75257031520Stradis STRADIS MEDICAL, LLCPVX2022-09-01
M75257026250STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-04-28
H65857029645Henry ScheinHENRY SCHEIN, INC.PVX2022-04-07
H65857029641Henry ScheinHENRY SCHEIN, INC.PVX2022-04-07
H65857029555Henry ScheinHENRY SCHEIN, INC.PVX2022-03-31
H65857029551Henry ScheinHENRY SCHEIN, INC.PVX2022-03-31
M7526180360STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-21
M7526180310STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-10
M75257015130STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-09
M7526180350STRADIS HEALTHCARESTRADIS MEDICAL, LLCPVX2022-03-09
10195594960384CARDINAL HEALTHCardinal Health 200, LLCPVX2021-04-06
50195594960382CARDINAL HEALTHCardinal Health 200, LLCPVX2021-04-06
10888439843606CARDINAL HEALTHCardinal Health 200, LLCPVX2020-11-09
10888439589399CARDINAL HEALTHCardinal Health 200, LLCPVX2019-10-17