FDA.reportPublic FDA data

GRAVES VAG SPEC LG 4.5

Primary DI
G422SP0030
Brand
GRAVES VAG SPEC LG 4.5
Company
BIOPSY FINE CUT INSTRUMENTS
Model
SP003
Catalog number
SP003
Published
2024-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G422SP0030PrimaryHIBCC0

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
645680898
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G422BP0110TISCHLER OVAL 21CMBP011BP0112024-10-03
G422BP0120TISCHLER KEVORKIAN BIOPSY PUNCHBP012BP0122023-11-28
G422BP0180"TISCHLER MORGAN BIOPSY PUNCH 10"""BP018BP0182023-10-13
G422BP0190"BABY TISCHLER BIOPSY PUNCH 10"""BP019BP0192023-10-13
G422BP1090"ROTO TISCHLER BIOPSY PUNCH 10"""BP109BP1092023-10-13
G422BP0181TISCHLER MORGAN BIOPSY PUNCH 10"BP018BP0182023-10-13
G422BP0191BABY TISCHLER BIOPSY PUNCH 10"BP019BP0192023-10-13
G422BP1091ROTO TISCHLER BIOPSY PUNCH 10"BP109BP1092023-10-13
G422DL0030MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MMDL003DL0032023-10-13
G422DL1010DILATOR CERVICAL SET OF 6DL101DL1012023-10-13
G422DL3000HANK DILATOR DOUBLE ENDED 7/8 FRDL300DL3002023-10-13
G422DL3010HANK DILATOR SET OF 6 (Z304)DL301DL3012023-10-13
G422FC0060INSTRUMENT F. REMOVAL OF I.U.D FC006FC0062023-10-13
G422LZ1080"Lletz TENACULUM FORCEPS 9.5"""LZ108LZ1082023-10-13
G422SP1040PEDERSON SPECULUM MEDIUMSP104SP1042023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850083275365Intrace USAPILOTIS TECH LLCHDF2026-07-03
00190776421632MillenniumAvalign Technologies, Inc.HDF2026-06-23
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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G586OB631721NCDT0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
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