AccessGUDID - DEVICE: CLIP 9 (03661624004750)

GUDID

Device Identifier (DI) Information

Brand Name: CLIP 9
Version or Model: L9180
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: L9180
Company Name: VITALITEC SURGICAL

Primary DI Number: 03661624004750
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 262783206 *Terms of Use

Device Description: Titanium Hemostatic Clip - Small/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
Height: 4.7 Millimeter

Device Record Status

Public Device Record Key: 0110dbaa-bad6-4c7c-b3a9-c9eadfb67906
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: September 17, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
03661624006501	48	03661624004767	2016-06-01	Not in Commercial Distribution	grouping carton
03661624004767	20	03661624004750	2016-06-01	Not in Commercial Distribution	clinical box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 508-7476033
Email: eknuppesi@aol.com

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