FDA.report

ROMERO Lordotic Rasp 14x14, H12mm

Primary DI
B806RO1018LA1214X140
Brand
ROMERO Lordotic Rasp 14x14, H12mm
Company
Spineup, Inc.
Model
RO1018LA1214X14
Catalog number
RO1018LA1214X14
Device description
ROMERO Lordotic Rasp 14x14, H12mm
Published
2024-05-07
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

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B806RO1018LA1214X140PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes

TypeValueUnit
Depth14Millimeter
Height12Millimeter
Width14Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
786-910-0234contact@upgroup.tech

Regulatory Flags

DUNS number
116999578
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
false
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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B806ISRO1214A06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214A06CB1ISRO1214A06CB12023-08-28
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B806ISRO1214A10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214A10CB1ISRO1214A10CB12023-08-28
B806ISRO1214A11CB10ROMERO CERVICAL CAGE, W14xD12xH11ISRO1214A11CB1ISRO1214A11CB12023-08-28
B806ISRO1214A12CB10ROMERO CERVICAL CAGE, W14xD12xH12ISRO1214A12CB1ISRO1214A12CB12023-08-28
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B806ISRO1214L06CB10ROMERO CERVICAL CAGE, W14xD12xH06ISRO1214L06CB1ISRO1214L06CB12023-08-24
B806ISRO1214L07CB10ROMERO CERVICAL CAGE, W14xD12xH07ISRO1214L07CB1ISRO1214L07CB12023-08-24
B806ISRO1214L08CB10ROMERO CERVICAL CAGE, W14xD12xH08ISRO1214L08CB1ISRO1214L08CB12023-08-24
B806ISRO1214L09CB10ROMERO CERVICAL CAGE, W14xD12xH09ISRO1214L09CB1ISRO1214L09CB12023-08-24
B806ISRO1214L10CB10ROMERO CERVICAL CAGE, W14xD12xH10ISRO1214L10CB1ISRO1214L10CB12023-08-24

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