FDA.report

Instraspec

Primary DI
05010058181007
Brand
Instraspec
Company
ROBINSON HEALTHCARE LIMITED
Model
8100 Vaginal Speculum Small
Catalog number
8100
Device description
Instraspec Contour 'Unbreakable' Vaginal Speculum - Small
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

Related Records

Contact Domains

Product Codes

CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications

CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058181007PackageGS125In Commercial Distribution
05010058281004PackageGS1100In Commercial Distribution
05010058081000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058181007050100581810075010058181007
05010058281004050100582810045010058281004
05010058081000050100580810005010058081000

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

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