AccessGUDID - DEVICE: RONDO' (08032909623129)

GUDID

Device Identifier (DI) Information

Brand Name: RONDO'
Version or Model: Box for ø5mm screws
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VP-93300
Company Name: CITIEFFE SRL

Primary DI Number: 08032909623129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 431406875 *Terms of Use

Device Description: No description.

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):	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?
12963	Pass-through cabinet	A specially designed cabinet, typically built-in, that facilitates the direct passage of goods, instruments, sets and kits from one zone to another zone without the personnel having to physically cross the boundaries themselves [e.g., from a supply trolley or loading bay into an operating room (OR)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTY	Pin, Fixation, Smooth
HTN	Washer, Bolt Nut
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113388	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Dry and clean environment and avoid damaging the packing. Room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc5baded-2b7c-4f64-9eba-75b039774f62
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 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: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +39051721850
Email: info@citieffe.com

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