FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962161982
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-36-150767
Catalog number
HNM-36-150767
Device description
PEDERSON VAGINAL SPECULUM, W/INTEGRATED SMOKE EVACUATION TUBE, LARGE
Published
2023-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KALRetractor, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962161982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962161982008429621619828429621619820842962161982

GMDN Terms#

Term, Definition table
TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
806754185
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841742143672HNM MEDICALHNM-1-09-8310SHNM-1-09-8310S2025-05-16
10841742149476HNM MEDICALHNM-1-09-8308SHNM-1-09-8308S2025-05-16
10841742149483HNM MEDICALHNM-1-09-8312SHNM-1-09-8312S2025-05-16
00841742149585HNM MedicalHNM-1-57-2097HNM-1-57-20972025-04-18
00841742149592HNM MedicalHNM-1-57-2099HNM-1-57-20992025-04-18
00841742149608HNM MedicalHNM-1-57-2098HNM-1-57-20982025-04-18
10841742149353HNM MedicalHNM-45-002HNM-45-0022025-01-27
10841742149377HNM MEDICALHNM-1-62-2210SHNM-1-62-2210S2025-01-27
10841742149384HNM MEDICALHNM-1-62-2215SHNM-1-62-2215S2025-01-27
10841742149391HNM MEDICALHNM-1-62-2220SHNM-1-62-2220S2025-01-27
00841742149233HNM MedicalHNM-1-550-1524HNM-1-550-15242024-11-18
00841742148939HNM MedicalHNM-250-000-011HNM-250-000-0112024-11-08
00841742148946HNM MedicalHNM-250-000-012HNM-250-000-0122024-11-08
00841742148953HNM MedicalHNM-250-000-013HNM-250-000-0132024-11-08
00841742149219HNM MedicalHNM-250-000-014HNM-250-000-0142024-11-08
10841742149124HNM MEDICALHBI-BA-100HBI-BA-1002024-08-30
10841742148929HNM MEDICALHNM-17506HNM-175062024-05-14
00841742148854HNM MedicalHNM-250-000-001HNM-250-000-0012024-04-01
00841742148861HNM MedicalHNM-250-000-002HNM-250-000-0022024-04-01
00841742148878HNM MedicalHNM-250-000-003HNM-250-000-0032024-04-01

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Primary DI, Brand, Company table
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