FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962163207
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
GAUGE30
Catalog number
GAUGE30
Device description
DEPTH GAUGE, 30MM LNGTH (Rev A)
Published
2023-05-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HDLRetractor, Vaginal
HTJGauge, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDLRetractor, VaginalObstetrics/Gynecology1
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962163207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962163207008429621632078429621632070842962163207

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
806754185
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812171026570HNM MEDICALHKW-11-090009HKW-11-0900092019-05-30
00812171026587HNM MEDICALHKW-11-090011HKW-11-0900112019-05-30
00812171026594HNM MEDICALHKW-11-090016HKW-11-0900162019-05-30
00812171026600HNM MEDICALHKW-11-090014HKW-11-0900142019-05-30
00812171026617HNM MEDICALHKW-11-060014HKW-11-0600142019-05-30
00812171026624HNM MEDICALHKW-11-120009HKW-11-1200092019-05-30
00812171026631HNM MEDICALHKW-13-090016HKW-13-0900162019-05-30
00812171026679HNM MEDICALHKW-11-040011HKW-11-0400112019-05-30
00812171026686HNM MEDICALHKW-11-040016HKW-11-0400162019-05-30
00812171026693HNM MEDICALHKW-11-040014HKW-11-0400142019-05-30
00812171026709HNM MEDICALHKW-11-050007HKW-11-0500072019-05-30
00812171026716HNM MEDICALHKW-11-090020HKW-11-0900202019-05-30
00812171026723HNM MEDICALHKW-11-090024HKW-11-0900242019-05-30
00812171026730HNM MEDICALHKW-11-090028HKW-11-0900282019-05-30
00812171026747HNM MEDICALHKW-11-090032HKW-11-0900322019-05-30
00812171026754HNM MEDICALHKW-11-090035HKW-11-0900352019-05-30
00812171026761HNM MEDICALHKW-11-090040HKW-11-0900402019-05-30
00812171026778HNM MEDICALHKW-11-090045HKW-11-0900452019-05-30
00812171026785HNM MEDICALHKW-15-090020HKW-15-0900202019-05-30
00812171026792HNM MEDICALHKW-15-090024HKW-15-0900242019-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
07898506814688QuinelatoSchobell Industrial LtdaHDL2023-01-09
07898506814695QuinelatoSchobell Industrial LtdaHDL2023-01-09
07898506814725QuinelatoSchobell Industrial LtdaHDL2023-01-09
07898506814749QuinelatoSchobell Industrial LtdaHDL2023-01-09
07898506815197QuinelatoSchobell Industrial LtdaHDL2023-01-09
07898506815203QuinelatoSchobell Industrial LtdaHDL2023-01-09
07898506815210QuinelatoSchobell Industrial LtdaHDL2023-01-09
07898506852246QuinelatoSchobell Industrial LtdaHDL2023-01-09
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
07898506813285QuinelatoSchobell Industrial LtdaHDL2022-12-08
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08800089402830Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
08806390873765VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-12-17
08806390863247Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390865869Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390867764Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390857963VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28