AccessGUDID - DEVICE: Direct Drive® Clip Applier (00607915117306)

GUDID

Device Identifier (DI) Information

Brand Name: Direct Drive® Clip Applier
Version or Model: CA090
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: APPLIED MEDICAL RESOURCES CORPORATION

Primary DI Number: 00607915117306
Issuing Agency: GS1
Commercial Distribution End Date: August 03, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 187129135 *Terms of Use

Device Description: Disposable Laparoscopic Clip Applier with 20 Clips

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:	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?
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZP	Clip, Implantable
MDM	Instrument, Manual, Surgical, General Use

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
Special Storage Condition, Specify: Handle with care. Product should be stored in a clean, cool, dry area away from chemical fumes.

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 10 Millimeter
Length: 32 Centimeter

Device Record Status

Public Device Record Key: e27cf892-a369-4eb5-be59-738401384bdb
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: March 20, 2015