AccessGUDID - DEVICE: STEALTH® FIBRA® CLAMP INSERT (00607915114824)

GUDID

Device Identifier (DI) Information

Brand Name: STEALTH® FIBRA® CLAMP INSERT
Version or Model: A0G14
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APPLIED MEDICAL RESOURCES CORPORATION

Primary DI Number: 00607915114824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187129135 *Terms of Use

Device Description: CLAMP INSERT

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?
15778	Clamp jaw cover	A device used in pairs that are placed/fitted onto the distal working end (the jaws) of a surgical instrument (e.g., vascular clamps, forceps) to improve atraumatic grip and pressure distribution when clamping an artery or a vein. It is typically a long cylindrical polymer tube available in various sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: Size 5

Device Record Status

Public Device Record Key: a2e5d5ce-6081-4816-96e5-1f3e091d6001
Public Version Date: September 06, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016