AccessGUDID - DEVICE: TracLux (M678TLS0)

GUDID

Device Identifier (DI) Information

Brand Name: TracLux
Version or Model: TLS2575, TLS25150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TLS2550, TLS25150
Company Name: SUNOPTIC TECHNOLOGIES LLC

Primary DI Number: M678TLS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094586898 *Terms of Use

Device Description: TracLux HandLite Retractor System, Retractor Handle and Retractor Blade kitted TLS2550 consist of one retractor handle (TLH001) and one retractor blade TLB2550 (25mm x 75mm) TLS25150 consist of one retractor handle (TLH001) and one retractor blade TLB25150 (25mm x 150mm) Retractor blades and retractor handle components are direct marked with the UDI-DI number M678HHR0

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

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: 48a4374c-06d2-4bcf-bcfc-5a63b7e21166
Public Version Date: May 16, 2025
Public Version Number: 1
DI Record Publish Date: May 08, 2025