FDA.reportPublic FDA data

JULIET INSTRUMENTATION

Primary DI
07640178981720
Brand
JULIET INSTRUMENTATION
Company
SpineArt SA
Model
SPE-IN 01 69-N
Catalog number
SPE-IN 01 69-N
Device description
DISC SHAVER
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LWKRazor, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWKRazor, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178981720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178981720076401789817207640178981720

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA 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#

Type, Value, Unit table
TypeValueUnit
Height14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07
07640221373045PERLA ® TLTLF-IN 01 60-N2026-05-07
07640221373052PERLA NAVNAV-IN 43 30-NNAV-IN 43 30-N2026-05-07
07640221373069PERLA NAVNAV-IN 43 60-NNAV-IN 43 60-N2026-05-07
07640221373076PERLA ® TLTLF-IN 03 70-N2026-05-07
07640221373083PERLA ® TLTLF-IN 12 00-N2026-05-07
07640221373090PERLA ® TLTLF-IN 04 70-N2026-05-07
07640221373113PERLA NAVNAV-IN 41 75-NNAV-IN 41 75-N2026-05-07
07640221373120PERLA NAVNAV-IN 41 80-NNAV-IN 41 80-N2026-05-07
07640221373137PERLA NAVNAV-IN 41 85-NNAV-IN 41 85-N2026-05-07
07640221373144PERLA NAVNAV-IN 41 90-NNAV-IN 41 90-N2026-05-07
07640221373151PERLA NAVNAV-IN 41 95-NNAV-IN 41 95-N2026-05-07
07640221373168PERLA NAVNAV-IN 41 00-NNAV-IN 41 00-N2026-05-07
07640221373175PERLA NAVNAV-IN 41 05-NNAV-IN 41 05-N2026-05-07
07640221373182PERLA NAVNAV-IN 41 10-NNAV-IN 41 10-N2026-05-07
07640221373199PERLA NAVNAV-IN 41 15-NNAV-IN 41 15-N2026-05-07
07640221373205PERLA NAVNAV-IN 41 20-NNAV-IN 41 20-N2026-05-07
07640221373212PERLA NAVNAV-IN 41 25-NNAV-IN 41 25-N2026-05-07
07640221373229PERLA NAVNAV-IN 42 70-NNAV-IN 42 70-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380213281CARDINAL HEALTHCardinal Health 200, LLCLWK2026-05-27
00197998192449Solventum™Solventum US LLCLWK2026-02-15
00197998192463Solventum™Solventum US LLCLWK2026-02-15
00197998192487Solventum™Solventum US LLCLWK2026-02-15
00197998192715Solventum™Solventum US LLCLWK2026-02-15
00197998192739Solventum™Solventum US LLCLWK2026-02-15
00197998192753Solventum™Solventum US LLCLWK2026-02-15
00197998276347Solventum™Solventum US LLCLWK2026-02-15
00197998315503Solventum™Solventum US LLCLWK2026-02-15
00197998315534Solventum™Solventum US LLCLWK2026-02-15
00197998192456Solventum™Solventum US LLCLWK2026-02-15
00197998192470Solventum™Solventum US LLCLWK2026-02-15
00197998192494Solventum™Solventum US LLCLWK2026-02-15
00197998192722Solventum™Solventum US LLCLWK2026-02-15
00197998192746Solventum™Solventum US LLCLWK2026-02-15
00197998192760Solventum™Solventum US LLCLWK2026-02-15
00197998276354Solventum™Solventum US LLCLWK2026-02-15
00197998315510Solventum™Solventum US LLCLWK2026-02-15
00197998315541Solventum™Solventum US LLCLWK2026-02-15
00661392011755LSL HEALTHCARELSL Industries, LLCLWK2025-10-30
107073878145783M™3M COMPANYLWK2025-03-28
507073878145763M™3M COMPANYLWK2025-03-28
00850063139328NEIL MEDICALNeil Medical GroupLWK2025-03-14
85006313932800NEIL MEDICALNeil Medical GroupLWK2025-03-14
107073878145853M™3M COMPANYLWK2024-08-19
107073878145923M™3M COMPANYLWK2024-08-19
107073878146083M™3M COMPANYLWK2024-08-19
107073878146153M™3M COMPANYLWK2024-08-19
507073878145833M™3M COMPANYLWK2024-08-19
507073878145903M™3M COMPANYLWK2024-08-19