FDA.reportPublic FDA data

VT1828-G

Primary DI
00850017652934
Brand
VT1828-G
Company
VERSAH, LLC
Model
VT1828-G
Published
2026-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017652934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017652934008500176529348500176529340850017652934

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081472844
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017652828Densah® Bur G3VT58682023-09-19
00810212140001VT1828-GSVT1828-GS2026-01-07
00810212140018VT2838-GSVT2838-GS2026-01-07
00810212140025VT3848-GSVT3848-GS2026-01-07
00810212140032VT4858-GSVT4858-GS2026-01-07
00810212140049VPLTT-GVPLTT-G2026-01-07
00810212140056VPLTT-GSVPLTT-GS2026-01-07
00810212140063VSINUSVSINUS2026-01-07
00850017652835Densah Bur HolderVBLK2026-01-07
00850017652842VT1525-GVT1525-G2026-01-07
00850017652859VT4555-GSVT4555-GS2026-01-07
00850017652866VT3545-GSVT3545-GS2026-01-07
00850017652873VT2535-GSVT2535-GS2026-01-07
00850017652880VT1525-GSVT1525-GS2026-01-07
00850017652897VT4858-GVT4858-G2026-01-07
00850017652903VT2535-GVT2535-G2026-01-07
00850017652910VT3545-GVT3545-G2026-01-07
00850017652927VT4555-GVT4555-G2026-01-07
00850017652941VT2838-GVT2838-G2026-01-07
00850017652958VT3848-GVT3848-G2026-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25
00810226101081AiraAIRA, LLCEJL2026-08-25