FDA.reportPublic FDA data

Graves Speculum

Primary DI
G165SU210040030
Brand
Graves Speculum
Company
ELMED INSTRUMENTS(PVT)LTD.
Model
SU-21-0040-03
Catalog number
SU-21-0040-03
Device description
Intended Use: Graves Vaginal Speculum is a gynecological instrument used for performing pelvic examinations, Pap Smears, and examining the cervixPackaging: Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50.
Published
2022-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HDFSpeculum, Vaginal, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G165SU210040030PrimaryHIBCC0

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
645680588
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
G165SU100095240SPONGE FORCEPSSU-10-0095-24SU-10-0095-242022-09-08
G165SU210296250Schroeder ForcepsSU-21-0296-25SU-21-0296-252022-09-08
G165SU70275140Metzenbaum ScissorsSU-7-0275-14SU-7-0275-142022-09-09
G165SU70333180Metzenbaum ScissorsSU-7-0333-18SU-7-0333-182022-09-09
G165SU70149110Operating ScissorsSU-7-0149-11SU-7-0149-112022-09-08
G165SU70149140Operating ScissorsSU-7-0149-14SU-7-0149-142022-09-08
G165SU70153110Operating ScissorsSU-7-0153-11SU-7-0153-112022-09-08
G165SU70153140Operating ScissorsSU-7-0153-14SU-7-0153-142022-09-08
G165SU70242140Mayo ScissorsSU-7-0242-14SU-7-0242-142022-09-08
G165SU70242230Mayo ScissorsSU-7-0242-23SU-7-0242-232022-09-08
G165SU71055110Iris ScissorSU-7-1055-11SU-7-1055-112022-09-08
G165SU71056110Iris ScissorSU-7-1056-11SU-7-1056-112022-09-08
G165SU71105110Strabismus ScissorsSU-7-1105-11SU-7-1105-112022-09-08
G165SU71151140Spencer Stitch ScissorsSU-7-1151-14SU-7-1151-142022-09-08
G165SU71220110Lister Bandage ScissorsSU-7-1220-11SU-7-1220-112022-09-08
G165SU71220140Lister Bandage ScissorsSU-7-1220-14SU-7-1220-142022-09-08
G165SU130176130Halsey Needle HolderSU-13-0176-13SU-13-0176-132022-09-09
G165SU130180130Webster Needle HolderSU-13-0180-13SU-13-0180-132022-09-09
G165SU130184120Derf Needle HolderSU-13-0184-12SU-13-0184-122022-09-09
G165SU130196140Baumgartner Needle HolderSU-13-0196-14SU-13-0196-142022-09-09

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B382SD915039080Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039140Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039150Surgical DirectSurgical Direct, Inc.HDF2026-08-21
00190776426439MillenniumAvalign Technologies, Inc.HDF2026-08-18
00190776426446MillenniumAvalign Technologies, Inc.HDF2026-08-18
00198506093944ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
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00850088713534PRINCETONPrinceton Medical Group, Inc.HDF2026-08-14
00190776408817MillenniumAvalign Technologies, Inc.HDF2026-08-03
00190776422639MillenniumAvalign Technologies, Inc.HDF2026-08-03
00198506093845ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-29
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00198506093418ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
B382SD915038100Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038120Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915039110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471000Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471130Surgical DirectSurgical Direct, Inc.HDF2026-07-28