AccessGUDID - DEVICE: Alexis Wound Protector-Retractor (00607915132958)

GUDID

Device Identifier (DI) Information

Brand Name: Alexis Wound Protector-Retractor
Version or Model: C8322
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APPLIED MEDICAL RESOURCES CORPORATION

Primary DI Number: 00607915132958
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187129135 *Terms of Use

Device Description: Wound Retractor and Protector

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?
47431	Radial surgical retractor	A sterile surgical device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It consists of an external and internal fixed or retracting ring interconnected with an elastomeric sleeve/sheath intended to also provide protection against wound contamination, and may include channels/tubing to allow wound-edge irrigation. Also known as a lap disc, hand access device, handport, or protector, it may be used with or without a seal cap for colorectal, urological, gynaecological, or general abdominal surgical procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGW	Ring (Wound Protector), Drape Retention, Internal

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
Device Size Text, specify: 2-4 cm

Device Record Status

Public Device Record Key: 718e0712-588e-428a-b349-f7daef5e7916
Public Version Date: September 04, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016