AccessGUDID - DEVICE: Greenwald Surgical Company, Inc. (10801334011901)

GUDID

Device Identifier (DI) Information

Brand Name: Greenwald Surgical Company, Inc.
Version or Model: 51200-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U530
Company Name: GRACE MANUFACTURING, INC.

Primary DI Number: 10801334011901
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 607903382 *Terms of Use

Device Description: Stamey Dorsal Vein Apical Retractor. Stainless steel throughout. Handle flange provides secure control and cephaled retraction. Retractor blades provide a wide space on both sides of the dorsal vein complex for placing a controlling suture.

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):	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?
13393	Vessel retractor	A hand-held, surgical instrument used for separating/drawing aside vascular structures to permit examination or intervention during a surgical procedure. It is typically a shaft-like instrument with an inwardly curved, saddle hook at the distal end and a handle at the proximal end. It may also be known as a vein retractor. It is made of high-grade stainless steel. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FGN	Retractor, Non-Self-Retaining

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: 130f579a-a389-41fd-8601-bf13804f2c68
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 31, 2016