AccessGUDID - DEVICE: STINGRAY SURGICAL PRODUCTS (B112G032160)

GUDID

Device Identifier (DI) Information

Brand Name: STINGRAY SURGICAL PRODUCTS
Version or Model: G03-216
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G03-216
Company Name: STINGRAY SURGICAL PRODUCTS L.L.C.

Primary DI Number: B112G032160
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024328124 *Terms of Use

Device Description: Stringer, Length 16.0" (40.6cm), Width 2.5" (6.4cm), Stainless Steel

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":	Yes
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?
64168	Sterilization stringer	A device designed to hang hinged, ring-handled surgical instruments (e.g. forceps, scissors) in an open position during sterilization. Often referred to as an instrument stringer, it is typically in the form of a U-/D-shaped locking bar. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

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: 3857a227-b629-45dd-9135-e674656a1de4
Public Version Date: August 07, 2024
Public Version Number: 2
DI Record Publish Date: May 20, 2021