AccessGUDID - DEVICE: SlingShot (07613252656616)

GUDID

Device Identifier (DI) Information

Brand Name: SlingShot
Version or Model: CAT02590
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAT02590
Company Name: STRYKER CORPORATION

Primary DI Number: 07613252656616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: SLINGSHOT 70 UP

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:	Yes
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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Suture/needle passer, single-use	A sterile, hand-held, manual surgical instrument designed for passing (driving) sutures and suture needles through tissues/prosthetic materials to facilitate suturing. A passer, also known as a needle driver, is a long, thin, rod-like device that may be flexible or rigid in design and have hooks, catches, clasps, or forceps-like jaws at the distal end that grip/hold. The distal end will typically terminate as a button, rounded, or acorn tip, while the proximal end will have a handle or lever that is operated by the user. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Suture/needle passer, single-use

A sterile, hand-held, manual surgical instrument designed for passing (driving) sutures and suture needles through tissues/prosthetic materials to facilitate suturing. A passer, also known as a needle driver, is a long, thin, rod-like device that may be flexible or rigid in design and have hooks, catches, clasps, or forceps-like jaws at the distal end that grip/hold. The distal end will typically terminate as a button, rounded, or acorn tip, while the proximal end will have a handle or lever that is operated by the user. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
HWQ	PASSER

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 70.0 degree

Device Record Status

Public Device Record Key: 912d3259-aa7c-4819-bc61-6894944035a4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 04, 2015