AccessGUDID - DEVICE: BX Series Reusable Biopsy Forceps (00666416130092)

GUDID

Device Identifier (DI) Information

Brand Name: BX Series Reusable Biopsy Forceps
Version or Model: BX210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BX210
Company Name: Primed Instruments Inc

Primary DI Number: 00666416130092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 254491293 *Terms of Use

Device Description: Reusable biopsy forceps with serrated jaws and needle. HIBC/UPN: M453BX2100

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:	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
NON	Forceps, Biopsy, Non-Electric, Reprocessed

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
Special Storage Condition, Specify: Biopsy forceps should be stored in the sterile package at room temperature in a clean and dry area away from direct sunlight. Each device is individually packaged.

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: 155cm

Device Record Status

Public Device Record Key: 9759bcde-97f6-4abd-8385-369520910c47
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 23, 2017