AccessGUDID - DEVICE: DORMO-STRIP (08427734036921)

GUDID

Device Identifier (DI) Information

Brand Name: DORMO-STRIP
Version or Model: VE-022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TCSS1
Company Name: TELIC SAU

Primary DI Number: 08427734036921
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 465170678 *Terms of Use

Device Description: Vein strippers are single use medical devices, sterilized by Ethylene Oxide, intended to be used for surgical stripping of varicose veins. This product is not intended to be used in the central venous system. Model VE-022 model is intended for conventional stripping procedures.

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":	Yes
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?
32321	Vein stripper, single-use	A sterile hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAJ	Stripper, Vein, Disposable

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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab722677-077b-496a-b338-9eb7b0ecc21d
Public Version Date: January 23, 2025
Public Version Number: 1
DI Record Publish Date: January 15, 2025