FDA.report

ELMED

Primary DI
00842180165892
Brand
ELMED
Company
ELMED INCORPORATED
Model
01-49367
Catalog number
01-49367
Device description
STAINLESS STEEL INSTRUMENT TRAY, 15x10-5/8x3/4"
Published
2023-03-23
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
LRPTray, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180165892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180165892008421801658928421801658920842180165892

GMDN Terms

TermDefinition
Instrument transport trolley systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.

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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00198506089732ELMED INCORPORATEDSTESS572004DSTESS572004D2026-03-20
00198506089749ELMED INCORPORATEDSTESS571004DSTESS571004D2026-03-20
00198506055393ELMED INCORPORATEDSTF9911FSTF9911F2026-03-19
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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
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