AccessGUDID - DEVICE: CROC Multiple Sample Single-Use Biopsy Forceps (40666416140235)

GUDID

Device Identifier (DI) Information

Brand Name: CROC Multiple Sample Single-Use Biopsy Forceps
Version or Model: MC924A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MC924A
Company Name: Primed Instruments Inc

Primary DI Number: 40666416140235
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: Single-Use Multiple Sample Biopsy Forceps with serrated jaws and ezSlide® sheath. HIBC/UPN: M453MC924A4

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:	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?
38711	Flexible endoscopic biopsy forceps, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCL	Forceps, Biopsy, Non-Electric

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Instruments should be stored in the sterile package at room temperature in a clean and dry area away from direct sunlight. Each case contains 16 dispenser boxes. Each dispenser box contains 5 devices.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Required Working Channel: 2.8mm
Device Size Text, specify: Jaw Diameter: 2.4mm
Device Size Text, specify: Working Length: 240cm

Device Record Status

Public Device Record Key: 0b0f76cf-3f16-4dc9-8483-5e069a7d3f0c
Public Version Date: December 24, 2018
Public Version Number: 1
DI Record Publish Date: November 22, 2018