FDA.report

ROMEO 2 INSTRUMENTATION

Primary DI
07640151084301
Brand
ROMEO 2 INSTRUMENTATION
Company
SpineArt SA
Model
ELL-IN 00 21-N
Catalog number
ELL-IN 00 21-N
Device description
SCREW DISTRACTOR
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
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640151084301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640151084301076401510843017640151084301

GMDN Terms

TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
07640221373380PERLA ® TLTLF-IN 05 70-NTLF-IN 05 70-N2026-02-09
07640151082482ROMEO 2 MISMIS-IN 04 01-NMIS-IN 04 01-N2026-02-05
07640151082499ROMEO 2 MISMIS-IN 05 01-NMIS-IN 05 01-N2026-02-05
07640332477854PERLA ®SPE-IN 01 63-NSPE-IN 01 63-N2026-02-05
07640375236081Cure OPEL-C1100-950-001100-950-002026-02-05
07640450868879PERLA ® TL MIS NAVNAV-BX 30 20-NNAV-BX 30 20-N2026-02-05
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07640332471548PERLA ® TLTLF-IN 23 60-NTLF-IN 23 60-N2026-01-05
07640185349650PERLA ® TLTLF-IN 13 30-NTLF-IN 13 30-N2025-11-20
07640270064178CURE ACP7-00001-187-00001-182025-11-20
07640270064192CURE ACP7-00001-207-00001-202025-11-20
07640270064215CURE ACP7-00001-227-00001-222025-11-20
07640270064239CURE ACP7-00001-247-00001-242025-11-20
07640270064291CURE ACP7-00001-307-00001-302025-11-20
07640270064345CURE ACPS1-7-00001-20S1-7-00001-202025-11-20
07640270064475CURE ACP7-00002-307-00002-302025-11-20
07640270064499CURE ACP7-00002-327-00002-322025-11-20

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