AccessGUDID - DEVICE: SURJEX (G383CLOWARDBLADERETRAF6)

GUDID

Device Identifier (DI) Information

Brand Name: SURJEX
Version or Model: WM9873320 to WM9873333
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WM9873320 to WM9873333
Company Name: SURJEX

Primary DI Number: G383CLOWARDBLADERETRAF6
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645518882 *Terms of Use

Device Description: CLOWARD BLADE RETRACTOR 7.5" BLADE 13MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 18MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 20MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 23MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 30MM WITH LIP CLOWARD BLADE RETRACTOR 7.5" BLADE 33MM WITH LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 13MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 18MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 20MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 23MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 30MM NO LIP CLOWARD MODI CERVICAL RETRACTOR BLADE 7.5" 33MM NO LIP

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:	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?
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 [?]
Ethylene Oxide

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: a9a8932f-d64e-4fce-9c1a-632bd06d0e43
Public Version Date: May 08, 2024
Public Version Number: 1
DI Record Publish Date: April 30, 2024