AccessGUDID - DEVICE: Gyrus ACMI (00821925004405)

GUDID

Device Identifier (DI) Information

Brand Name: Gyrus ACMI
Version or Model: 332S8
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyrus ACMI, LLC

Primary DI Number: 00821925004405
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007198742 *Terms of Use

Device Description: Flexible Cystoscopic Foreign Body Forceps, Single-Action, Stem Only 8 Fr (2.7 mm) 35 cm

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?
38810	Flexible endoscopic biopsy forceps, reusable	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOA	SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

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
No Device Sizes

Device Record Status

Public Device Record Key: 61dd2379-739c-4e13-bad8-c5f8c953ee10
Public Version Date: September 02, 2024
Public Version Number: 4
DI Record Publish Date: September 11, 2018