AccessGUDID - DEVICE: Filshie® Clip Applicator, 5mm SI (05055515602138)

GUDID

Device Identifier (DI) Information

Brand Name: Filshie® Clip Applicator, 5mm SI
Version or Model: AVM-880
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AVM-880
Company Name: FEMCARE LIMITED

Primary DI Number: 05055515602138
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 500218573 *Terms of Use

Device Description: Reusable Filshie Clip Applicators for single incision laparoscopy

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:	No
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?
33598	Fallopian tube clip/band	An implantable device applied externally to the fallopian tube(s) to constrict the tube and prevent the passage of ova. It is typically used during tubal ligation procedures and functions as a contraceptive device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KNH	Device, Occlusion, Tubal, Contraceptive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P920046	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 440ad04e-db20-40c1-ad4c-9ba69436110b
Public Version Date: December 23, 2022
Public Version Number: 6
DI Record Publish Date: September 25, 2014