AccessGUDID - DEVICE: Biopsy Forceps Handle Type 2 shape follow master sample and customer manual (B832BPS20010)

GUDID

Device Identifier (DI) Information

Brand Name: Biopsy Forceps Handle Type 2 shape follow master sample and customer manual
Version or Model: BPS2001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BPS2001
Company Name: IAA SURGICAL INSTRUMENTS COMPANY

Primary DI Number: B832BPS20010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645387382 *Terms of Use

Device Description: No description.

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):	No
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?
31248	Bronchoscopic biopsy curette, flexible, reusable	A flexible device intended to be used through a flexible bronchoscope to obtain specimens of the bronchi for histological/pathological diagnosis during bronchoscopy. It is a type of biopsy forceps whose flexible insertion portion is made of a metal coil or a plastic tube, but where at the distal end terminates in a sharply-pointed scoop/receptacle for securing the biopsy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	Forceps

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: 463bfa0d-4df6-4b5a-8e04-ac667aced4c6
Public Version Date: February 16, 2023
Public Version Number: 1
DI Record Publish Date: February 08, 2023