AccessGUDID - DEVICE: FLOWSYS ERGO HF (04048223083987)

GUDID

Device Identifier (DI) Information

Brand Name: FLOWSYS ERGO HF
Version or Model: 1299-81-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1299-81-00
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223083987
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use
Previous DI: 04048223030066

Device Description: 1299-81-00

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?
47829	Surgical instrument handle, non-torque-limiting	A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 226a9963-c499-40f6-933d-c4fa4b95d3f7
Public Version Date: July 22, 2021
Public Version Number: 4
DI Record Publish Date: April 02, 2021