FDA.report

Instraspec

Primary DI
05010058188709
Brand
Instraspec
Company
ROBINSON HEALTHCARE LIMITED
Model
8870
Catalog number
8870
Device description
Instraspec Contour Vaginal Speculum Medium X 25
Published
2022-08-12
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

Related Records

Contact Domains

Product Codes

CodeName
HIBSpeculum, vaginal, nonmetal

Product Code Classifications

CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058188709PackageGS125In Commercial Distribution
05010058088702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058188709050100581887095010058188709
05010058088702050100580887025010058088702

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep out of sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+441909735502CustomerService.Worksop@vernagroup.com

Regulatory Flags

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
false
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

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