AccessGUDID - DEVICE: MicroKnife XL (08714729172017)

GUDID

Device Identifier (DI) Information

Brand Name: MicroKnife XL
Version or Model: M00532810
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729172017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Triple Lumen Needle Knife

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?
65185	ERCP catheter, non-balloon, electrosurgical	A flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papilla (papillotomy) and approximate tissues, during endoscopic retrograde cholangiopancreatography (ERCP). It includes proximal controls, a distal monopolar electrosurgical cutting wire and an inner lumen(s); it does not incorporate a balloon. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, electrosurgical, endoscopic (with or without accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Device Size Text, specify: 5.5 F Diameter
Device Size Text, specify: 1.8 mm Diameter

Device Record Status

Public Device Record Key: 5cefe4be-bd96-4254-b979-349baf14c8e9
Public Version Date: January 14, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2016

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

[?]

No Customer Contact currently defined

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