AccessGUDID - DEVICE: Disposable Scalpels Sterile #15 (30818087010697)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Scalpels Sterile #15
Version or Model: 12901500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12901500
Company Name: PROPPER MANUFACTURING COMPANY, INC.

Primary DI Number: 30818087010697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 001483130 *Terms of Use

Device Description: Disposable Scalpels Sterile #15

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:	Yes
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?
12253	Skin grafting knife	A hand-held, one-piece, manual surgical instrument designed to cut donor-site skin strips intended for grafting. It has a knife-like design with a flat broad blade and a sharp cutting edge; it is usually made of stainless steel. This device may reflect old technology. This is a reusable 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: 9e1bfdb3-30e8-41fa-8a74-578f5ce85b9f
Public Version Date: June 22, 2021
Public Version Number: 2
DI Record Publish Date: March 06, 2020