FDA.reportPublic FDA data

MONARCH DISPOSO-SPEC

Primary DI
00613970002006
Brand
MONARCH DISPOSO-SPEC
Company
MONARCH MOLDING, INC.
Model
200C
Catalog number
200CA
Device description
CLEAR PLASTIC DISPOSABLE (ONE TIME USE) SPECULUM - SIZE MEDIUM100/EACH PER CASE 4 BAGS OF 25/EACH
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00613970002006PrimaryGS10
10613970002003Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613970002006006139700020066139700020060613970002006
1061397000200310613970002003

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

Contacts#

Phone, Email table
PhoneEmail
620-767-5115mmonarch@tctelco.net

Regulatory Flags#

DUNS number
007136203
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00613970014856MONARCH DISPOSABLE ANOSCOPE1485C1485C2016-09-14
00613970018908MONARCH DISPOSABLE ANOSCOPE1890C1890C2016-09-14
00613970018915MONARCH DISPOSABLE ANOSCOPE1891C1891C2016-09-14
00613970018922MONARCH DISPOSABLE ANOSCOPE1891W1891W2016-09-14
00613970001009MONARCH DISPOSO- SPEC100C100CA2016-09-14
00613970001016MONARCH DISPO-SPEC100C100CC2016-09-14
00613970002013MONARCH DISPOSO-SPEC200C200CB2016-09-14
00613970002020MONARCH DISPOSO-SPEC200C200CC2016-09-14
00613970003003MONARCH DISPOSO-SPEC300W300WA2016-09-14

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