FDA.report

SCARLET AL-T INSTRUMENTATION

Primary DI
07640185340633
Brand
SCARLET AL-T INSTRUMENTATION
Company
SpineArt SA
Model
SCA-IN 14 12-N
Catalog number
SCA-IN 14 12-N
Device description
DISC SHAVER
Published
2018-12-10
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
FZSCurette, Surgical, General Use

Product Code Classifications

CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640185340633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640185340633076401853406337640185340633

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
Height10Millimeter

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
M93071015043S20Life Instruments Life Instrument CorporationFZS2026-03-23
M93071015044S20Life InstrumentsLife Instrument CorporationFZS2026-03-23
04052536215539tezoUlrich GmbH & Co. KGFZS2026-03-16
04052536215546tezoUlrich GmbH & Co. KGFZS2026-03-16
00810130207367MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207374MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207381MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207398MSIModern Surgical Instruments LLCFZS2026-03-12
04052536017560tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017577tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017584tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017751tezoUlrich GmbH & Co. KGFZS2026-03-12
00810158219182PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
00810158219199PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
M93071015043SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
M93071015044SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
00810158218802PRINCETONPrinceton Medical Group, Inc.FZS2026-02-05
04059453143389Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZS2026-02-02
M9307120160110Life Instruments Life Instrument CorporationFZS2026-02-02
00810158218598PRINCETONPrinceton Medical Group, Inc.FZS2026-01-16
00810158218604PRINCETONPrinceton Medical Group, Inc.FZS2026-01-16
00841731142474Hintermann Series VILEX LLCFZS2026-01-16
00810158218505PRINCETONPrinceton Medical Group, Inc.FZS2026-01-15
M930712150000Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150010Life InstrumentsLife Instrument CorporationFZS2026-01-09
M9307121501110Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150200Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150210Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150300Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150310Life InstrumentsLife Instrument CorporationFZS2026-01-09