AccessGUDID - DEVICE: Castroviejo Needle Holder (curved) (non glare) (10697660003419)

GUDID

Device Identifier (DI) Information

Brand Name: Castroviejo Needle Holder (curved) (non glare)
Version or Model: 25-014
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Oculo-Plastik Inc

Primary DI Number: 10697660003419
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257382580 *Terms of Use

Device Description: The Needle-Holder is an instrument intended to hold the suturing needle for the closing of incisions. It locks when it grips the needle or thread. All non-glare, except for the closure mechanism. This instrument is usually not used at the same time as the laser.

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?
12726	Suturing needle holder, reusable	A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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
Length: 5.5 Inch
Length: 14 Centimeter

Device Record Status

Public Device Record Key: a1c59a56-f5ad-45e2-b7c1-32a0c32144d6
Public Version Date: January 08, 2021
Public Version Number: 2
DI Record Publish Date: November 21, 2019