AccessGUDID - DEVICE: Anmuth Medical International (08403207004543)

GUDID

Device Identifier (DI) Information

Brand Name: Anmuth Medical International
Version or Model: 28-150-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28-150-24
Company Name: Anmuth Medical International, LLC

Primary DI Number: 08403207004543
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 786500830 *Terms of Use

Device Description: OCHSNER Trocar 24 FR

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):	No
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?
12990	Amniotic membrane perforator, reusable	A surgical instrument used to rupture the amniotic membrane (i.e., the amnion - the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid) to assist in childbirth, without causing injury to the mother or foetus. It is typically long and shaft-like, and terminates in a rounded nose with a sharp hook. It is typically made of high-grade stainless steel or durable plastic materials, and may be straight or curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotome or forceps and/or a trocar. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBM	Cannula and trocar, suprapubic, non-disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Length: 6 Inch

Device Record Status

Public Device Record Key: 1d1b44fe-f9e9-4976-ba0a-1fa340b8d745
Public Version Date: July 09, 2024
Public Version Number: 1
DI Record Publish Date: July 01, 2024