AccessGUDID - DEVICE: Bishop Dressing Forceps (G25006013090)

GUDID

Device Identifier (DI) Information

Brand Name: Bishop Dressing Forceps
Version or Model: 06-013-09
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06-013-09
Company Name: N S SURGICAL COMPANY

Primary DI Number: G25006013090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645681649 *Terms of Use

Device Description: A hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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?
42500	Dressing/utility forceps, tweezers-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.	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 [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
Ultraviolet Light

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 8.5 Centimeter

Device Record Status

Public Device Record Key: 6e029dbc-1626-4f41-aeeb-6afb9d6fbf95
Public Version Date: May 04, 2023
Public Version Number: 1
DI Record Publish Date: April 26, 2023