AccessGUDID - DEVICE: Symmetry Surgical® (00887482173718)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical®
Version or Model: 51-7510
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 51-7510
Company Name: SYMMETRY SURGICAL INC.

Primary DI Number: 00887482173718
Issuing Agency: GS1
Commercial Distribution End Date: July 22, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079641356 *Terms of Use

Device Description: Guide, Van Buren Catheter, Curved, Size 8

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?
46690	Gastro-urological guidewire, reusable	A metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBA	Catheter, Balloon Type

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: 758b0d47-1387-4f13-a4bd-2203861a1479
Public Version Date: December 23, 2024
Public Version Number: 3
DI Record Publish Date: September 21, 2022