AccessGUDID - DEVICE: Martin Dissector (00840663102570)

GUDID

Device Identifier (DI) Information

Brand Name: Martin Dissector
Version or Model: 4200-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4200-10
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663102570
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: Martin Dissector

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):	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?
37335	Intraluminal artery stripper, single-use	A sterile, hand-held, manual surgical instrument designed to perform an endarterectomy (the removal of plaque deposits from arteriosclerotic arteries) during a vasculature reconstruction procedure. It is typically made of high-grade stainless steel and is available in various designs including an endohelic form (a tubular device with an expanding helical element at the distal tip which is controlled by the surgeon through a sliding mechanism on the handle). Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWX	Stripper, Artery, Intraluminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003719	000

Device Exempt from Premarket Submission: No 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: 7d7dd385-89d6-4e4c-aea4-37765d523a3e
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: June 30, 2015

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

Customer Contact

[?]

Phone: 781-221-2266
Email: csus@lemaitre.com

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