AccessGUDID - DEVICE: CLIP 9 VITALITEC (03661522039434)

GUDID

Device Identifier (DI) Information

Brand Name: CLIP 9 VITALITEC
Version or Model: B9324
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B9324
Company Name: PETERS SURGICAL

Primary DI Number: 03661522039434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 265741780 *Terms of Use
Previous DI: 03661624006594

Device Description: Titanium Hemostatic Clip - Medium Size

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
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

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: Store the unopened sterile package in a cool, dry area, with good ventilation away from areas of extreme temperature and humidity.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: medium

Device Record Status

Public Device Record Key: 4fe08661-be70-47c1-97aa-159fcde737e6
Public Version Date: July 12, 2023
Public Version Number: 3
DI Record Publish Date: August 01, 2019