AccessGUDID - DEVICE: Sterishot II Elite Kit (15055515602371)

GUDID

Device Identifier (DI) Information

Brand Name: Sterishot II Elite Kit
Version or Model: AVM-954
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AVM-954
Company Name: FEMCARE LIMITED

Primary DI Number: 15055515602371
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 500218573 *Terms of Use

Device Description: Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator, 8mm Bladeless Trocar and one pair of Filshie® 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:	Yes
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	008

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 in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0fe989d-01b1-432d-ad8f-012a4b95ea7b
Public Version Date: March 08, 2021
Public Version Number: 2
DI Record Publish Date: January 14, 2021