AccessGUDID - DEVICE: Pro-Tec (00686209051014)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-Tec
Version or Model: Stainless Steel F1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05-0101
Company Name: Dectro International

Primary DI Number: 00686209051014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 246237945 *Terms of Use

Device Description: Hair-removal electrolysis probes, single-use

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?
63883	Hair-removal electrolysis system needle electrode, single-use	A sterile device designed as a needle-shaped electrode used together with a hair-removal electrolysis system and used to destroy the dermal papilla (hair root) through application of an electric current from the parent device via the tip of this device that is inserted close to the hair shaft, under the skin, and into the dermal papilla. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCW	Epilator, High Frequency, Needle-Type

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: 428c5f18-07b8-4252-a42a-fb339ea0978c
Public Version Date: October 17, 2024
Public Version Number: 1
DI Record Publish Date: October 09, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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