AccessGUDID - DEVICE: CROC Series Endoscopic Device (40666416140136)

GUDID

Device Identifier (DI) Information

Brand Name: CROC Series Endoscopic Device
Version or Model: RC924
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RC924
Company Name: Primed Instruments Inc

Primary DI Number: 40666416140136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: Single-use wide angled retrieval device with rat tooth/alligator hybrid jaws and ezSlide® sheath. HIBC/UPN: M453RC9244

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?
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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: 230cm

Device Record Status

Public Device Record Key: 6cb88bf4-44ae-429f-b2cb-23dd53c11956
Public Version Date: August 21, 2019
Public Version Number: 4
DI Record Publish Date: October 23, 2017