AccessGUDID - DEVICE: Surgical Direct (B382SD16664600)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD1666460
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SD1666460
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD16664600
Issuing Agency: HIBCC
Commercial Distribution End Date: April 11, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: 5mm 34cm Retractor, Triangular, Straight 60mm WL

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?
45182	Self-retaining surgical retractor, reusable	A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974382	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: bf95fc1c-d117-4a04-857d-3adcc697bf66
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: April 06, 2023