AccessGUDID - DEVICE: Surgical Direct (B382SD26130)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD2613
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD2613
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD26130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: 3.5mm Fiber Light Cable (ACMI, Stryker Light Source to ACMI, Stryker scope) 10ft long

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: 185b9041-6a09-4824-849b-ac1c96525ac6
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: November 23, 2022