FDA.reportPublic FDA data

Coated Graves Specula

Primary DI
00348783004755
Brand
Coated Graves Specula
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9086502
Device description
Coated Graves Specula Large
Published
2024-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00348783004755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783004755003487830047553487830047550348783004755

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA 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 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 at an angle. It is typically made of stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810158211360PRINCETONPrinceton Medical Group, Inc.HDF2026-06-23
05060212052339Cusco Specula Metal SmallDTR MEDICAL LIMITEDHDF2026-06-10
05060212052346Cusco Specula Metal MediumDTR MEDICAL LIMITEDHDF2026-06-10
05060212052360Cusco Specula Metal LargeDTR MEDICAL LIMITEDHDF2026-06-10
05060411982314Cusco Specula Metal Large LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982321Cusco Specula Metal Large Extra LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982369Cusco Specula Metal BroadDTR MEDICAL LIMITEDHDF2026-06-10
05060411984462Cusco Specula Metal Medium LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411985117Cusco Specula Metal Small XXLongDTR MEDICAL LIMITEDHDF2026-06-10
00198506091490ELMED INCORPORATEDELMED INCORPORATEDHDF2026-06-09
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