AccessGUDID - DEVICE: Reciproc Minima (J003TSTRCPM621AST1)

GUDID

Device Identifier (DI) Information

Brand Name: Reciproc Minima
Version or Model: TSTRCPM621AST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TSTRCPM621AST
Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl

Primary DI Number: J003TSTRCPM621AST1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480538495 *Terms of Use

Device Description: Reciproc Minima Assortment (2x20, 2x25, 1x 35, 1x45), 21mm

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):	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?
65550	Luminal device flushing tubing set, single-use	A collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKS	FILE, PULP CANAL, ENDODONTIC

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: No
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: 0ec54a14-5c47-48fa-866c-282d7b2e20d3
Public Version Date: July 30, 2025
Public Version Number: 1
DI Record Publish Date: July 22, 2025