FDA.report

NA

Primary DI
10888551010108
Brand
NA
Company
STERILMED, INC.
Model
ETHACE23E
Catalog number
ETHACE23E
Device description
HARMONIC ACE PISTOL GRIP W/TORQUE WRENCH
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NLQScalpel, ultrasonic, reprocessed

Product Code Classifications

CodeDeviceSpecialtyClass
NLQSingle-Use Reprocessed Ultrasonic Surgical InstrumentsUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888551010108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088855101010810888551010108

GMDN Terms

TermDefinition
Soft-tissue ultrasonic surgical system holder/tip, reprocessedA sterile, hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, and is typically made of metal. This device is utilized in a variety of surgical disciplines. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(888)541-0078customerservice@sterilmed.com

Regulatory Flags

DUNS number
175899459
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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