FDA.reportPublic FDA data

Instraspec

Primary DI
05010058081000
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
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
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058181007PackageGS125In Commercial Distribution
05010058281004PackageGS1100In Commercial Distribution
05010058081000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058181007050100581810075010058181007
05010058281004050100582810045010058281004
05010058081000050100580810005010058081000

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

Contacts#

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

Regulatory Flags#

DUNS number
237799775
Device count
1
Premarket exempt
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
00199536930063BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930070BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930087BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930094BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930100BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930117BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00888937027389OfficeSPECCoopersurgical, Inc.HIB2026-08-06
00888937027396HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027402HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027419HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027426ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027433ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027440ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027457ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027464ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027327ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027334ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027341ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027358HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027365HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027372HER-SpecCoopersurgical, Inc.HIB2026-08-05
00860015815705Rosa SpeculumMY VILLAGE INNOVATIONS INC.HIB2026-07-20
20860000270421Nella Next Reusable Vaginal SpeculumCEEK WOMEN'S HEALTHHIB2026-06-25
00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
10860008900323ClearSpecClearspec LLCHIB2025-10-29
10860008900330ClearSpecClearspec LLCHIB2025-10-29