AccessGUDID - DEVICE: AHLGeneric (05056009101236)

GUDID

Device Identifier (DI) Information

Brand Name: AHLGeneric
Version or Model: 009X7
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED HEALTHCARE LTD.

Primary DI Number: 05056009101236
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 298822065 *Terms of Use

Device Description: Temporary Cavity Filling Material

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):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Gynaecological biopsy forceps, reusable	A hand-held manual surgical instrument designed to obtain biopsy specimens from gynaecological tumours or other gynaecological tissues during a surgical procedure for histopathological examination. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. The distal tip usually consists of two shaped cutting heads with sharp edges, one fitting exactly into the other, which facilitates the cutting of the biopsy. It is available in various sizes. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Gynaecological biopsy forceps, reusable

A hand-held manual surgical instrument designed to obtain biopsy specimens from gynaecological tumours or other gynaecological tissues during a surgical procedure for histopathological examination. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. The distal tip usually consists of two shaped cutting heads with sharp edges, one fitting exactly into the other, which facilitates the cutting of the biopsy. It is available in various sizes. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental

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: No
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: dfdfec90-fdf5-4cc9-afe5-dcff906bbbe5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 06, 2016