DEVICE: ROMEO 2 INSTRUMENTATION (07640139349613)

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Device Record History
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Device Identifier (DI) Information
ROMEO 2 INSTRUMENTATION
MIS-IN 42 00-N
In Commercial Distribution
MIS-IN 42 00-N
SpineArt SA
07640139349613
GS1

1
483016148 *Terms of Use
DISTRACTION FORCEPS
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62591 Implant handling forceps, alligator
A hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It is shaped like alligator- or crocodile-forceps, having a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
GEN Forceps, General & Plastic Surgery
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
6982360c-4078-4d19-926d-07bb506bd463
January 21, 2019
1
December 21, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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