FDA.report

AED-SLT KIT

Primary DI
00848657069441
Brand
AED-SLT KIT
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
AED-SLT KIT
Catalog number
AED-SLT KIT
Device description
A complete set of AED-SLT hermetic seal testers for Midas Rex, Stryker, Dyonics, Conmed Linvatec and Arthrex medical power tools including a hand-held aneroid sphygmomanometer with pressure inflation bulb
Published
2020-07-29
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
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657069441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657069441008486570694418486570694410848657069441

GMDN Terms

TermDefinition
Surgical power tool maintenance unitA device used for the automatic internal lubrication and maintenance of surgical power tools (e.g., pneumatically or electrically driven motors, turbines, or attachments). This device will automatically run programs for the lubrication of the internal components with service oil and flushing with compressed air after external cleansing, but prior to sterilization. This process is intended to improve performance and safety of the surgical instruments. The unit is designed to accept different handpieces which are connected directly or via adaptors to the unit's processing chamber.

Sterilization Methods

Method

Contacts

PhoneEmail
8182272720customerservice@aed.md

Regulatory Flags

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

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