AccessGUDID - DEVICE: Filshie® Clips (05055515602114)

GUDID

Device Identifier (DI) Information

Brand Name: Filshie® Clips
Version or Model: AVM-851J
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AVM-851J
Company Name: FEMCARE LIMITED

Primary DI Number: 05055515602114
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: The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes.

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":	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?
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: 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
No Device Sizes

Device Record Status

Public Device Record Key: d0bb3f36-599f-416d-ac2a-c0fdf30b6c54
Public Version Date: December 23, 2022
Public Version Number: 6
DI Record Publish Date: June 22, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
15055515602111	10	05055515602114	2022-06-30	Not in Commercial Distribution	Carton
25055515602118	20	15055515602111	2022-06-30	Not in Commercial Distribution	Overpack