AccessGUDID - DEVICE: NA (10888551019033)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: ETHLCSC1HA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ETHLCSC1HA
Company Name: STERILMED, INC.

Primary DI Number: 10888551019033
Issuing Agency: GS1
Commercial Distribution End Date: April 17, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: HARMONIC SCALPEL COAGULATING SHEARS GENERATOR 300 CURVED SHEARS (GEN04 ONLY)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61845	Soft-tissue ultrasonic surgical system holder/tip, reprocessed	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NLQ	Scalpel, ultrasonic, reprocessed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012571	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9a591e15-2e13-4e6d-b476-e5db6952673e
Public Version Date: September 10, 2019
Public Version Number: 6
DI Record Publish Date: September 22, 2016