AccessGUDID - DEVICE: ROMEO® 2 (07640151088323)

GUDID

Device Identifier (DI) Information

Brand Name: ROMEO® 2
Version or Model: ELL-IN 00 42-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ELL-IN 00 42-S
Company Name: SpineArt SA

Primary DI Number: 07640151088323
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483016148 *Terms of Use

Device Description: CEMENT FILLER PP

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?
47737	Orthopaedic cement injection cannula	A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PML	Bone Cement, Posterior Screw Augmentation
NKB	Thoracolumbosacral Pedicle Screw System
KWP	Appliance, Fixation, Spinal Interlaminal

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
No Device Sizes

Device Record Status

Public Device Record Key: 59aade53-32c9-40dd-9947-3392a3128330
Public Version Date: March 31, 2025
Public Version Number: 3
DI Record Publish Date: June 27, 2023

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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