AccessGUDID - DEVICE: ELMED (00842180196124)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: ST232021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST232021
Company Name: ELMED INCORPORATED

Primary DI Number: 00842180196124
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: Screw Extractor with Speed Lock, 3.95mm - 9.5mm screws, 9.25” (23.5cm) Overall Length, Jaw Width – 11mm, Jaw Length – 5cm

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?
44044	Cardiac myoplasty electrical stimulation system lead	An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be attached to the heart and/or the muscle wrapped around the heart (during myoplasty) to make an electrical connection between the system pulse generator and the muscle(s) to assist the heart in its pumping function.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 99ac97be-b39a-4d12-a3e7-fe377a0639a7
Public Version Date: April 25, 2024
Public Version Number: 1
DI Record Publish Date: April 17, 2024