FDA.report

AED

Primary DI
00848657010139
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
SDLP1130
Device description
Extra-Long Lap Tray. Lightweight polymer. Manufactured from medical grade polymer Radel-R©. Length 25.5" x Width 12" x Height 5.5"
Published
2017-11-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NWVLaparoscopic accessories, gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657010139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657010139008486570101398486570101390848657010139

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
839138955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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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