AccessGUDID - DEVICE: LiNA OperaScopeTM Lasso (05708265011889)

GUDID

Device Identifier (DI) Information

Brand Name: LiNA OperaScopeTM Lasso
Version or Model: OP-LAS16-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OP-LAS16-3
Company Name: Lina Medical ApS

Primary DI Number: 05708265011889
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305088619 *Terms of Use

Device Description: LiNA OperaScopeTM Lasso is intended for use in hysteroscopy 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":	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?
62615	Mechanical-cutting endoscopic polypectomy snare	A sterile, flexible, non-powered (i.e., not electrosurgical) device intended to be inserted through an endoscope to ensnare and cut polyps or other mucosal lesions during endoscopic surgery. It typically consists of a flexible sheath with a sharp cutting snare loop attached to the distal end of the sheath, and a handle which mechanically controls snaring through manual action. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAE	Snare, Surgical

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: f7c00a12-48f1-485d-9ab8-6110bf7e23f5
Public Version Date: August 11, 2020
Public Version Number: 1
DI Record Publish Date: August 03, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05708265011896	3	05708265011889		In Commercial Distribution

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +48612222149
Email: info.poland@lina-medical.com

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