FDA.report

ROMEO 2 INSTRUMENTATION

Primary DI
07640151080846
Brand
ROMEO 2 INSTRUMENTATION
Company
SpineArt SA
Model
ELL-IN 01 34-N
Catalog number
ELL-IN 01 34-N
Device description
REDUCER T-HANDLE
Published
2018-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWNInstrument, Compression

Product Code Classifications

CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640151080846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640151080846076401510808467640151080846

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
483016148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07640221373359PERLA ® TLTLF-IN 36 10-NTLF-IN 36 10-N2026-02-09
07640221373366PERLA ® TLTLF-IN 36 00-NTLF-IN 36 00-N2026-02-09
07640221373373PERLA ® TLTLF-IN 05 60-NTLF-IN 05 60-N2026-02-09
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07640270064178CURE ACP7-00001-187-00001-182025-11-20
07640270064192CURE ACP7-00001-207-00001-202025-11-20
07640270064215CURE ACP7-00001-227-00001-222025-11-20
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