AccessGUDID - DEVICE: ELITE MEDICAL INSTRUMENTATION (G569EMISU34900020)

GUDID

Device Identifier (DI) Information

Brand Name: ELITE MEDICAL INSTRUMENTATION
Version or Model: EMI-SU3490-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EMI-SU3490-002 RETRACTOR
Company Name: ELITE MEDICAL INSTRUMENTATION

Primary DI Number: G569EMISU34900020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116733674 *Terms of Use

Device Description: Retractor, Richardson Eastman, Double Ended, Large, 1 3/4" x 1 1/2", 2 1/2" x 1 5/8"

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?
33542	Bone hook	A hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIG	Retractor, All Types

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: 8fc96a0c-e940-4de7-b529-c4e601b97314
Public Version Date: March 06, 2024
Public Version Number: 1
DI Record Publish Date: February 27, 2024