AccessGUDID - DEVICE: Endocraft LLC (00860009975187)

GUDID

Device Identifier (DI) Information

Brand Name: Endocraft LLC
Version or Model: UMG105-LCN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UMG105-LCN
Company Name: Endocraft, LLC

Primary DI Number: 00860009975187
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039432148 *Terms of Use

Device Description: Fiber optic light carrier for surgical illumination through endoscope. Connects to Light cable.

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):	No
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?
32241	Fibreoptic operating light system	A system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)

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 [?]
Ethylene Oxide
Dry Heat Sterilization
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: 9de3c7f2-c6ab-4f41-b40b-c3125e9ca1fc
Public Version Date: July 31, 2023
Public Version Number: 1
DI Record Publish Date: July 21, 2023