FDA.report

HNM Medical

Primary DI
00842962145166
Brand
HNM Medical
Company
HNM STAINLESS, LLC.
Model
HNM-1-61-0361
Catalog number
HNM-1-61-0361
Device description
HOUSE ROSEN TYPE NEEDLE, 6 1/2", SEMI SHARP, STRONG CVD
Published
2023-04-17
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

Related Records

Product Codes

CodeName
JYTPick, Microsurgical Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYTPick, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842962145166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962145166008429621451668429621451660842962145166

GMDN Terms

TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. This is a reusable device.

Sterilization Methods

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
false
Sterilization required before use
true

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