AccessGUDID - DEVICE: Norsen Debrider, Sterile (00860371002306)

GUDID

Device Identifier (DI) Information

Brand Name: Norsen Debrider, Sterile
Version or Model: AB137
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BEL-MED, INC.

Primary DI Number: 00860371002306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068936807 *Terms of Use

Device Description: Norsen Debrider, Sterile

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?
35760	Dermabrasion brush, manual	A hand-operated device with wire bristles that is used to manually plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GED	Brush, Dermabrasion, Manual

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: ef92960f-c0e6-4ff3-8108-f7e473b36713
Public Version Date: June 06, 2019
Public Version Number: 1
DI Record Publish Date: May 29, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
40860371002304	40	00860371002306	In Commercial Distribution	box
30860371002307	30	00860371002306	In Commercial Distribution	box
20860371002300	50	00860371002306	In Commercial Distribution	box
10860371002303	25	00860371002306	In Commercial Distribution	box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-426-2740
Email: agnes@bel-medinc.com

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