FDA.reportPublic FDA data

Moore Medical

Primary DI
20607415001833
Brand
Moore Medical
Company
MOORE MEDICAL LLC
Model
68723
Device description
Vaginal Speculum Lrg
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HIBSpeculum, Vaginal, Nonmetal

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020726000DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEDukal Corp.2002-05-15HIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40607415001844PackageGS110In Commercial Distribution
20607415001833PrimaryGS10
10607415003847Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4060741500184440607415001844
2060741500183320607415001833
1060741500384710607415003847

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051420107
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607415001850Moore Medical932642016-12-09
10607415001874Moore Medical932672016-12-09
10607415001898Moore Medical932632016-12-09
10607415001911Moore Medical932662016-12-09
10607415001935Moore Medical932682016-12-09
10607415001959Moore Medical93269 2016-12-09
10607415001973Moore Medical932702016-12-09
10607415003656Moore Medical932652016-12-09
20607415000072Moore Medical827902016-12-09
20607415000096Moore Medical827912016-12-09
20607415000119Moore Medical827892016-12-09
10607415001614Moore Medical830302016-12-09
20607415001314Moore Medical137842016-12-09
20607415000010Moore Medical128422016-12-09
20607415000034Moore Medical128432016-12-09
20607415000058Moore Medical128442016-12-09
10607415001294Moore Medical137862016-12-09
10607415002055Moore Medical306442016-12-09
10607415002062Moore Medical306492016-12-09
10607415001997Moore Medical141702016-12-09

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