AccessGUDID - DEVICE: NA (10888551039482)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: RAD11161
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RAD11161
Company Name: STERILMED, INC.

Primary DI Number: 10888551039482
Issuing Agency: GS1
Commercial Distribution End Date: April 17, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 175899459 *Terms of Use

Device Description: FEMORAL COMPRESSION SYSTEM FEMOSTOP PLUS HD -- HEMOSTATIC DRESSING NOT INCLUDED --

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47927	Femoral artery compression system, manual, single-use	A noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure; it may in addition be used on brachial and radial arteries or after venipuncture. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It may be used in conjunction with dressings/haemostatic agents (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NMF	Clamp, vascular, reprocessed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120204	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 7d39d1e9-625f-4ea3-8822-f199bbf4b48b
Public Version Date: February 03, 2023
Public Version Number: 8
DI Record Publish Date: September 22, 2016