FDA.reportPublic FDA data

ELMED

Primary DI
00842180180840
Brand
ELMED
Company
ELMED INCORPORATED
Model
EL-AU15040
Catalog number
EL-AU15040
Device description
House knives. Mirror and satin finish. Overall length 6-1/2in (16.5cm). Sickle.
Published
2023-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180180840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180180840008421801808408421801808400842180180840

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091667ELMED INCORPORATED32-509-04-I32-509-04-I2026-07-10
00198506091759ELMED INCORPORATED31430-00B31430-00B2026-07-10
00198506091803ELMED INCORPORATEDSTE3220413IVSTE3220413IV2026-07-10
00198506091810ELMED INCORPORATED31960-3131960-312026-07-10
00198506091827ELMED INCORPORATEDSTE321211AISTE321211AI2026-07-10
00198506091834ELMED INCORPORATEDSTE321212AISTE321212AI2026-07-10
00198506091841ELMED INCORPORATED31960-3631960-362026-07-10
00198506091858ELMED INCORPORATED31960-6331960-632026-07-10
00198506091865ELMED INCORPORATED20-2771820-277182026-07-10
00198506091872ELMED INCORPORATED9839FS9839FS2026-07-10
00198506091889ELMED INCORPORATED31560-2131560-212026-07-10
00198506091612ELMED INCORPORATED24129-10B-KW24129-10B-KW2026-06-24
00198506091629ELMED INCORPORATED24129-08B-KW24129-08B-KW2026-06-24
00198506091506ELMED INCORPORATED53020-7853020-782026-06-10
00198506091513ELMED INCORPORATEDSTE3212113ISTE3212113I2026-06-10
00198506091520ELMED INCORPORATEDSTE3212313ISTE3212313I2026-06-10
00198506091537ELMED INCORPORATED32007-1532007-152026-06-10
00198506091544ELMED INCORPORATED32006-1532006-152026-06-10
00198506091551ELMED INCORPORATED23-2503LH23-2503LH2026-06-10
00198506091575ELMED INCORPORATED23-6020-1323-6020-132026-06-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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