AccessGUDID - DEVICE: Symmetry Surgical (00887482073643)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical
Version or Model: 45-1013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 45-1013
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482073643
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: CONE VENTRICULAR NEEDLE 2 HOLE LUER LOCK 15G

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?
42372	Soft-tissue biopsy needle, reusable	A sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of soft tissue percutaneously, typically for the pathological analysis of the specimen's cellular elements. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	Instrument, Surgical, Non-Powered

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: bff81fb1-8e3f-479e-bda4-83233a74d895
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 08, 2016