AccessGUDID - DEVICE: Surgical Direct (B382SD9141781260)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD914178126
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD914178126
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD9141781260
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: Modified Kolbel Retractor, Double Prong, Blunt Tips

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?
12036	Eye muscle hook, reusable	A hand-held manual surgical instrument designed to be used to locate and hook extraocular muscles, typically during strabismus correction surgery. It is a slender instrument with a bent blunt distal end and a handle, available in several sizes; some hooks with a very fine shank are designed to allow suture placement behind the hook, providing greater suture security (i.e., better muscle attachment). It is not designed for intraocular use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGN	RETRACTOR, NON-SELF-RETAINING

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: f98d4b07-f357-42b6-9a44-e2e54f52b6eb
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: December 02, 2022