AccessGUDID - DEVICE: TLC Self-Retaining Retractor System (00842071144418)

GUDID

Device Identifier (DI) Information

Brand Name: TLC Self-Retaining Retractor System
Version or Model: ETLC601
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ETLC601, TLC601
Company Name: APPLIED MEDICAL TECHNOLOGY, INC.

Primary DI Number: 00842071144418
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038101861 *Terms of Use

Device Description: TLC Disposable Deavers (Sterile, Pouched), MDR

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
62562	Hand-held surgical retractor, single-use	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 single-use 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 3f6cb90e-73d9-45b0-a13b-6f648dc4f08b
Public Version Date: November 04, 2024
Public Version Number: 1
DI Record Publish Date: October 25, 2024