AccessGUDID - DEVICE: Precision Plus Safety Scalpel (00620974003649)

GUDID

Device Identifier (DI) Information

Brand Name: Precision Plus Safety Scalpel
Version or Model: 73-0710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 73-0710
Company Name: Southmedic Incorporated

Primary DI Number: 00620974003649
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 246848147 *Terms of Use

Device Description: #10 Sterile Precision Plus Safety Scalpel

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
47569	Scalpel, single-use	A hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GES	BLADE, 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: Yes
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: 2faad13a-7e60-4288-8a0f-7c85589ab180
Public Version Date: February 21, 2024
Public Version Number: 1
DI Record Publish Date: February 13, 2024