AccessGUDID - DEVICE: Scalpel, Handle 35cm for #11 blades (04057034120620)

GUDID

Device Identifier (DI) Information

Brand Name: Scalpel, Handle 35cm for #11 blades
Version or Model: 34-7471
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 34-7471
Company Name: Geister Medizintechnik GmbH

Primary DI Number: 04057034120620
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343548848 *Terms of Use

Device Description: Scalpel, Handle 35cm for #11 blades ValveGate™

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?
12235	Scalpel handle, reusable	A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDZ	HANDLE, SCALPEL

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: b25fd198-e676-4564-a15c-66b6e007b67f
Public Version Date: August 01, 2023
Public Version Number: 1
DI Record Publish Date: July 24, 2023