AccessGUDID - DEVICE: Hemorrhage Occluder Pin with Applicator (00861838000316)

GUDID

Device Identifier (DI) Information

Brand Name: Hemorrhage Occluder Pin with Applicator
Version or Model: HOP-AP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HOP-AP
Company Name: TOOLS FOR SURGERY, LLC

Primary DI Number: 00861838000316
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 841842441 *Terms of Use

Device Description: Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery. Also available with applicator.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
35884	Skin stapler/staple, non-bioabsorbable	A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDW	Staple, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040109	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
Length: 7 Millimeter
Outer Diameter: 10 Millimeter

Device Record Status

Public Device Record Key: 732b824a-c3a3-450e-bb16-e13223a30e03
Public Version Date: March 10, 2021
Public Version Number: 2
DI Record Publish Date: September 26, 2019