FDA.reportPublic FDA data

PRECICE® Instruments

Primary DI
00812258029005
Brand
PRECICE® Instruments
Company
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Model
DBS2-3.4
Catalog number
DBS2-3.4
Device description
Orthopedic surgical instrument - 3.4 mm drill bit, short
Published
2017-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812258029005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812258029005008122580290058122580290050812258029005

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-use, sterileA sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-435-5477csdepartment@nuvasive.com
866-456-2871info@globusmedical.com

Regulatory Flags#

DUNS number
837845234
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
00195377108555PRECICETPT6-110-B-S2023-10-04
00195377108562PRECICETPT6-105-B-S2023-10-04
00195377108579PRECICETPT6-100-B-S2023-10-04
00195377108586PRECICETPT6-950-B-S2023-10-04
00195377108593PRECICETPT6-900-B-S2023-10-04
00195377108609PRECICETPT6-850-B-S2023-10-04
00195377108623PRECICETPT6-750-B-S2023-10-04
00195377108630PRECICETPT6-700-B-S2023-10-04
00195377108647PRECICETPT6-650-B-S2023-10-04
00195377108654PRECICETPT6-600-B-S2023-10-04
00195377108661PRECICETPT6-110-A-S2023-10-04
00195377108678PRECICETPT6-105-A-S2023-10-04
00195377108685PRECICETPT6-100-A-S2023-10-04
00195377108692PRECICETPT6-950-A-S2023-10-04
00195377108708PRECICETPT6-900-A-S2023-10-04
00195377108715PRECICETPT6-850-A-S2023-10-04
00195377108722PRECICETPT6-800-A-S2023-10-04
00195377108739PRECICETPT6-750-A-S2023-10-04
00195377108746PRECICETPT6-700-A-S2023-10-04
00195377108753PRECICETPT6-650-A-S2023-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRLHTW2026-07-23
B803SYN31005100ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310230ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310650ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310660ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310670ORTHOMEDORTHO-MED, INC.HTW2026-07-22
B803SYN310680ORTHOMEDORTHO-MED, INC.HTW2026-07-22
00190776403270MillenniumAvalign Technologies, Inc.HTW2026-07-21
08059386748688Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2026-07-21
B504OM19S17050BrasselerProvisionHTW2026-07-20
B504OM3162880SynthesProvisionHTW2026-07-20
B504OM4058830BiometProvisionHTW2026-07-20
B504OM4058890BiometProvisionHTW2026-07-20
B504OM542022S0StrykerProvisionHTW2026-07-20
B504OM7024470StrykerProvisionHTW2026-07-20
B504OMA37330MedartisProvisionHTW2026-07-20
B504OMAR1214L0ArthrexProvisionHTW2026-07-20
B504OMAR1217L0ArthrexProvisionHTW2026-07-20
B504OMCSS07247SQ0WrightProvisionHTW2026-07-20
B504OMKM166310260BrasselerProvisionHTW2026-07-20
B504OMKM166310680BrasselerProvisionHTW2026-07-20
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17