AccessGUDID - DEVICE: Integra® Padgett® Dermatomes (10381780282365)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Padgett® Dermatomes
Version or Model: 3539250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3539250
Company Name: INTEGRA LIFESCIENCES CORPORATION

Primary DI Number: 10381780282365
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 963856096 *Terms of Use

Device Description: Model B (120V) - Dermatome Complete Kit - USA/Canada Only

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
11179	Dermatome handpiece, electrically-powered	An electrically-powered, hand-held surgical instrument designed to cut from the body (harvest) thin donor slices of skin for skin grafting, or to excise small skin lesions, using a dedicated insertable blade (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFD	DERMATOME

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
No Device Sizes

Device Record Status

Public Device Record Key: c28f9392-bd14-44e5-9e6e-ee845088ebb1
Public Version Date: June 22, 2021
Public Version Number: 2
DI Record Publish Date: March 09, 2018