FDA.report

ELMED

Primary DI
00842180185166
Brand
ELMED
Company
ELMED INCORPORATED
Model
09321-15
Catalog number
09321-15
Device description
OPERATING SCISSORS, FINE, REYNOLDS, CURVED, 15CM
Published
2024-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRWScissors, General, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180185166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180185166008421801851668421801851660842180185166

GMDN Terms

TermDefinition
General-purpose surgical scissors, reusableA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
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00198506089701ELMED INCORPORATEDSTE5502610ASTE5502610A2026-03-20
00198506089718ELMED INCORPORATEDSTE235920STE2359202026-03-20
00198506089732ELMED INCORPORATEDSTESS572004DSTESS572004D2026-03-20
00198506089749ELMED INCORPORATEDSTESS571004DSTESS571004D2026-03-20
00198506055393ELMED INCORPORATEDSTF9911FSTF9911F2026-03-19
00198506089602ELMED INCORPORATED11126-1111126-112026-03-17
00198506089619ELMED INCORPORATEDSTE3610810600STE36108106002026-03-17
00198506089626ELMED INCORPORATED23-31-040223-31-04022026-03-17
00198506089633ELMED INCORPORATED40-652540-65252026-03-17
00198506089640ELMED INCORPORATED30670-2830670-282026-03-17
00198506089657ELMED INCORPORATED42-170042-17002026-03-17
00198506089664ELMED INCORPORATED38-1093-I38-1093-I2026-03-17
00198506089671ELMED INCORPORATED69127-0369127-032026-03-17
00198506089688ELMED INCORPORATED69127-0269127-022026-03-17
00198506089510ELMED INCORPORATEDSTE11510929STE115109292026-03-13

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00190776394127MillenniumAvalign Technologies, Inc.LRW2026-03-11
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00810158218987PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158218994PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158219168PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00192896122734Metzenbaum ScissorsSONTEC INSTRUMENTS, INC.LRW2026-03-10
04058749117462NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749121995NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749122008NAFehling Instruments GmbH & Co. KGLRW2026-03-05
00198506088605ELMED INCORPORATEDELMED INCORPORATEDLRW2026-02-23
00190776417277MillenniumAvalign Technologies, Inc.LRW2026-02-20
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00810058670540ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
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00840306837340Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LRW2026-02-18
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04059453062468Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-02-13
09348811000873INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-13
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