FDA.reportPublic FDA data

SST Pro Tip

Primary DI
08800066100094
Brand
SST Pro Tip
Company
SeoulinMedicare Co.,Ltd.
Model
SST Pro Tip 0.8
Published
2022-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFGBit, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800066100094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066100094088000661000948800066100094

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Regulatory Flags#

DUNS number
688896704
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800066110024N-DERMSLM-10012022-06-07
08800066100056SST Pro TipSST Pro Tip 0.32022-05-27
08800066100063SST Pro TipSST Pro Tip 0.42022-05-27
08800066100070SST Pro TipSST Pro Tip 0.52022-05-27
08800066100087SST Pro TipSST Pro Tip 0.62022-05-27
08800066100100SST Pro TipSST Pro Tip 1.02022-05-27
08800066110017SST ProSLM-10012022-05-27
08800066170035ProfacialSLM-7654E2022-05-27
08800066190026PlasonSLM-96002022-05-27
08809540050023Plasma showerSLM-90022022-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843193102447Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102454Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102461Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102478Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102485Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102492Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102508Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193102515Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193115706Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00843193115713Prodisc C InstrumentCentinel Spine, LLCGFG2026-09-25
00860016074101CARTISTEM® Subchondral Bone Drill Bit - 4mmMedipost, Inc.GFG2026-07-28
008405368002063P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
008405368002133P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
008405368002203P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
00811714036540ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036557ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
10888277326200MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277348813MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354005MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354012MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354029MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354074MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354296MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277355057MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378261MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378278MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277387805MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10080196393152MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277322295MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277329485MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29