AccessGUDID - DEVICE: Surgical Direct (B382SD57531150)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD5753115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD5753115
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD57531150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: 3.8mm 10 ft 3.8mm 10 ft Autoclavable Fiber Light Cable, Blue, Light Source Type: ACMI/Circon, Scope Type: Pilling Push and Twist Type

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?
35507	Fibreoptic light cable	A flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFS	image, illumination, fiberoptic, for endoscope

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021931	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: 4ea9c803-2e45-4c2e-8fee-f6f64ccab275
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: May 08, 2023