AccessGUDID - DEVICE: Delasco ADAPT/6 Needle Adapter (00609960000305)

GUDID

Device Identifier (DI) Information

Brand Name: Delasco ADAPT/6 Needle Adapter
Version or Model: ADAPT/6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADAPT/6
Company Name: DERMATOLOGIC LAB AND SUPPLY, INC.

Primary DI Number: 00609960000305
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021628771 *Terms of Use

Device Description: These needle adapters allow you to attach a metal hub needle to any electrosurgical unit. The adapters have a 3/32" (2.4mm) diameter shaft size, which fits most electrosurgical units. ADAPT/6 has a shaft (1 3/8") which was designed specifically for the Delasco 734/1134 and Aaron/Bovie handpieces. This will fit most other electrosurgical units as well but may stick out of the handpiece slightly longer. Luer lock connection, reusable and convenient. Accepts metal hub, Luer Lock needles. This device is subject to direct marking, but excepted due to technological infeasibility.

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":	No
For Single-Use:	No
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?
61876	Open-surgery electrosurgical electrode, monopolar, reusable	An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001029	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 56e5af0c-61af-473f-a07b-ef6087d5706b
Public Version Date: August 29, 2018
Public Version Number: 3
DI Record Publish Date: June 15, 2016