AccessGUDID - DEVICE: Symmetry Zep (00887482151860)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Zep
Version or Model: 52-9971
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52-9971
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482151860
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Atraumatic Hysterectomy Forcep Off Angled 12"

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?
35081	Haemostatic forceps	A hand-held manual surgical instrument designed to constrict blood vessels during surgery to prevent bleeding. Often referred to as a haemostat (hemostat), it typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will typically have short or long narrow blades that can be straight or curved. The blades are finely serrated to provide extra grip on the blood vessels. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HCZ	Forceps, Surgical, Gynecological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: e856f950-2c19-47a2-bedf-835de2236b47
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2016