FDA.reportPublic FDA data

ELMED

Primary DI
00842180155701
Brand
ELMED
Company
ELMED INCORPORATED
Model
18-2536
Catalog number
18-2536
Device description
FLOSEAL NEEDLE, 15DG., BEND, FEMALE LUER LOCK, 4 1/2" OVERAL LENGTH, 3 1/2" WORKING LENGTH, 1/4" ENLARGED TIP
Published
2023-03-01
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
GENForceps, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180155701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180155701008421801557018421801557010842180155701

GMDN Terms

TermDefinition
X-linked spinal and bulbar muscular atrophy (Kennedy's disease) IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inherited genetic disorder x-linked spinal and bulbar muscular atrophy or Kennedy's disease, associated with mutations in the androgen receptor (AR) gene with a repeat trinucleotide (CAG) expansion, using a nucleic acid technique (NAT).

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

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00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
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00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes

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00198506091124ELMED INCORPORATEDELMED INCORPORATEDGEN2026-05-26
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00846159039313SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039337SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039344SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039375SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039436SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039443SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039450SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039498SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039511SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
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00846159039535SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039542SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26