AccessGUDID - DEVICE: Frame adapter thumb screw (07290114061407)

GUDID

Device Identifier (DI) Information

Brand Name: Frame adapter thumb screw
Version or Model: Frame adapter thumb screw
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700-001330-00
Company Name: ALPHA OMEGA ENGINEERING CO. LTD.

Primary DI Number: 07290114061407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531856466 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
32556	Depth electrode	An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZL	Electrode, Depth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051830	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Dry Heat 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: ce732b4b-63c9-4def-b5b3-1267ec605831
Public Version Date: January 16, 2024
Public Version Number: 1
DI Record Publish Date: January 08, 2024