FDA.reportPublic FDA data

Feeler Gauge - Thick

Primary DI
07290115934847
Brand
Feeler Gauge - Thick
Company
PREMIA SPINE LTD
Model
87353
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182598000VersaLink™ Fixation SystemPremia Spine, Ltd.2018-11-13NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115934847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115934847072901159348477290115934847

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115932492Tower ST886062026-06-01
07290115932751Alignment Gauge Medium862022026-06-01
07290115932898Cannulated Screwdriver External sleeve865132026-06-01
07290115934076Tower ST Long Window889742026-06-01
07290115935622Cannulated Screwdriver Inner Shaft Short882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy Short882652026-06-01
07290115935646Cannulated Screwdriver External sleeve Short882662026-06-01
07290115935653Cannulated Screwdriver Handle Assy XL872452026-06-01
07290115935660Cannulated Screwdriver Inner Shaft XL871542026-06-01
07290115935837MIS Tower Guide86261N2026-06-01
07290014381254ProMIS™ Fixation System875112026-05-25
07290014381261ProMIS™ Fixation System875122026-05-25
07290115935615Counter Torque ST83142N2026-05-25
07290115932553VersaLink Bender825842024-10-01
07290115935479Rod Bender862972024-10-01
07290014381223SST 316 LVM, L=470, Ø1.5 over the K-Wire878512024-09-05
07290115934816K-Wire, Blunt Sharp Tip, L=450, Ø1.7mm XL KWA873022024-09-05
07290014381148SST 316 LVM, Blunt-Sharp Tip, L=600, Ø1.7 Power Drill874472024-09-05
07290014381155SST 316 LVM, Blunt Beveled Tip, L=230, Ø1.7 ShidiTechnique872092024-09-05
07290014381162SST 316 LVM, Blunt-Beveled Tip, L=470, Ø1.7 over the K-Wire872082024-09-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157059590ZAVATION RODZavation LLCNKB2026-06-04
00197157059606ZAVATION RODZavation LLCNKB2026-06-04
00197157059613ZAVATION RODZavation LLCNKB2026-06-04
00197157059620ZAVATION RODZavation LLCNKB2026-06-04
00197157059637ZAVATION RODZavation LLCNKB2026-06-04
00197157059644ZAVATION RODZavation LLCNKB2026-06-04
00197157059651ZAVATION RODZavation LLCNKB2026-06-04
00197157059668ZAVATION RODZavation LLCNKB2026-06-04
00197157059491ZAVATION RODZavation LLCNKB2026-06-03
00197157059507ZAVATION RODZavation LLCNKB2026-06-03
00197157059514ZAVATION RODZavation LLCNKB2026-06-03
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00840311245079Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311245130Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
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