AccessGUDID - DEVICE: Sentient Manufacturing (00860007603747)

GUDID

Device Identifier (DI) Information

Brand Name: Sentient Manufacturing
Version or Model: 3041310
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sentient Manufacturing, LLC

Primary DI Number: 00860007603747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106674754 *Terms of Use

Device Description: Sentient Manufacturing Laser Fiber Cleaver

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:	No
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?
48016	Laser fibre cleaving tool	A non-sterile, manually-operated instrument used to cleave (remove with a clean cut) the tip of a reusable laser fibre, e.g., a laser-beam delivery device. It is designed to be placed on a flat solid surface away from the clinical setting, and the end of the fibre to be cut is manually scored when passed across the cutting cleaver (e.g., a diamond coated wheel). It is used to cleave the fibre core to remove cracked, chipped, and damaged tips from a reusable medical device so that this can be successfully reused for further procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: bf4267cf-8653-48ea-8ee6-5c46a81b266a
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: September 16, 2022

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

Customer Contact

[?]

No Customer Contact currently defined

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