AccessGUDID - DEVICE: Hemorrhage Occluder Pin with Applicator (00868742000104)

GUDID

Device Identifier (DI) Information

Brand Name: Hemorrhage Occluder Pin with Applicator
Version or Model: CR1007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CR1007
Company Name: SURGIN SURGICAL INSTRUMENTATION, INC.

Primary DI Number: 00868742000104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076656164 *Terms of Use

Device Description: Hemorrhage Occluder Pin Standard - 10 mm head

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:	Yes
Prescription Use (Rx):	No
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?
46121	Haemorrhage control pin	A thumbtack-like implant typically intended to be used during pelvic surgery to control severe, localized bleeding from veins in the presacral area. It is implanted through a presacral vein into the sacrum (fused vertebral bones of the lower spine) after other methods of haemostasis (e.g., cauterization, suturing, clamping) have been determined ineffective. The device is made of metal [e.g., titanium (Ti)], having a large disk-like head and a serrated shaft. It may be attached to a disposable pin applicator that helps the surgeon position it prior to pressing it into place.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GDW	Staple, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890447	000

Device Exempt from Premarket Submission: No 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
Width: 10 Millimeter

Device Record Status

Public Device Record Key: 03b709cf-b3b0-4d9b-8454-bbfef1dce6d7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 20, 2015