AccessGUDID - DEVICE: EARP Retractor (00810135960670)

GUDID

Device Identifier (DI) Information

Brand Name: EARP Retractor
Version or Model: EARP-R_001-80
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NVISION BIOMEDICAL TECHNOLOGIES, INC.

Primary DI Number: 00810135960670
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047486041 *Terms of Use

Device Description: EARP Retractor, EARP BLADE 80. The EARP Retractor is used in conjunction with TeDan Phantom ML MIS Lumbar Surgical Access System ML-2000 to assist with focal retraction, to increase working corridor and improve line of sight to working area.

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
MDM	Instrument, Manual, Surgical, General Use

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: f074c531-242c-46b9-add4-36e294d3e5df
Public Version Date: October 26, 2023
Public Version Number: 2
DI Record Publish Date: September 28, 2023