FDA.report

ROMEO 2 INSTRUMENTATION

Primary DI
07640178984066
Brand
ROMEO 2 INSTRUMENTATION
Company
SpineArt SA
Model
ELL-IN 10 28-N
Catalog number
ELL-IN 10 28-N
Device description
Rod template L100
Published
2017-10-27
Public version status
Update
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640178984066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640178984066076401789840667640178984066

GMDN Terms

TermDefinition
Medical ruler, single-useA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not dedicated to wound measurements. This is a single-use device.

Device Sizes

TypeValueUnit
Length100Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
483016148
Device count
1
DM exempt
false
Premarket exempt
true
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
07640450866479BAGUERA CLID-BX 04 00-NLID-BX 04 00-N2026-01-30
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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