AccessGUDID - DEVICE: Symmetry Surgical STONEY (00887482084472)

GUDID

Device Identifier (DI) Information

Brand Name: Symmetry Surgical STONEY
Version or Model: 55-6097
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 55-6097
Company Name: ASPEN SURGICAL PRODUCTS, INC.

Primary DI Number: 00887482084472
Issuing Agency: GS1
Commercial Distribution End Date: October 08, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 027680821 *Terms of Use

Device Description: SPLENO-RENO SHUNT CLAMP 9 5/8"

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?
42468	Clamp manipulation forceps	A hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

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: d0a160bf-9619-47cc-81b1-6e77d9f1e722
Public Version Date: October 29, 2025
Public Version Number: 6
DI Record Publish Date: June 10, 2016