FDA.reportPublic FDA data

Instraspec

Primary DI
05010058181038
Brand
Instraspec
Company
ROBINSON HEALTHCARE LIMITED
Model
8103 Vaginal Speculum Large
Catalog number
8103
Device description
Instraspec Contour 'Unbreakable' Vaginal Speculum Large
Published
2020-11-26
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058181038PackageGS125In Commercial Distribution
05010058281035PackageGS1100In Commercial Distribution
05010058081031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058181038050100581810385010058181038
05010058281035050100582810355010058281035
05010058081031050100580810315010058081031

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
858 4871859Bob.duffy@mdpps-inc.com

Regulatory Flags#

DUNS number
237799775
Device count
1
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
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

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