FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962146866
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-61-0012
Catalog number
HNM-1-61-0012
Device description
BRUENING NON MAGNIFYING LENS
Published
2023-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOHSpectacle, Operating (Loupe), Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOHSpectacle, Operating (Loupe), OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962146866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962146866008429621468668429621468660842962146866

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
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
04049584035714BIOM 6 HD Optic Set for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035721BIOM 6 HD Optic Set for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035738BIOM 6 HD Optic Set for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049584035745BIOM 6 HD Optic Set for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2026-01-14
04049539106889EyeMag Smart TTLCarl Zeiss Meditec AGHOH2025-01-22
04049539106896EyeMag ClassicCarl Zeiss Meditec AGHOH2025-01-22
04049584029591BIOM ready+ 175, for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029607BIOM ready+ 200, for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029447BIOM ready+ 175, for f=175 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049584029454BIOM ready+ 200, for f=200 mmOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungHOH2024-09-11
04049539101341EyeMag SmartCarl Zeiss Meditec AGHOH2023-11-08
04049539101358EyeMag Pro SCarl Zeiss Meditec AGHOH2023-11-08
04049539101365EyeMag Pro FCarl Zeiss Meditec AGHOH2023-11-08
00810114911006SurgiTelSurgitelHOH2023-07-25
00810114911013SurgiTelSurgitelHOH2023-07-25
00810114911020SurgiTelSurgitelHOH2023-07-25
00810114911037SurgiTelSurgitelHOH2023-07-25
00810114911044SurgiTelSurgitelHOH2023-07-25
00810114911051SurgiTelSurgitelHOH2023-07-25
00810114911068SurgiTelSurgitelHOH2023-07-25
00810114911075SurgiTelSurgitelHOH2023-07-25
00810114911082SurgiTelSurgitelHOH2023-07-25
00810114911099SurgiTelSurgitelHOH2023-07-25
00810114911105SurgiTelSurgitelHOH2023-07-25
00810114911112SurgiTelSurgitelHOH2023-07-25
00810114911129SurgiTelSurgitelHOH2023-07-25
00810114911136SurgiTelSurgitelHOH2023-07-25
00810114910320SurgiTelSurgitelHOH2023-04-26
00810114910337SurgiTelSurgitelHOH2023-04-26
00810114910344SurgiTelSurgitelHOH2023-04-26