FDA.reportPublic FDA data

Overwatch PCF

Primary DI
00840606195607
Brand
Overwatch PCF
Company
SPINAL ELEMENTS, INC.
Model
33058-000
Device description
Tap, 4.5 mm, NAV-M
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606195607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606195607008406061956078406061956070840606195607

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7606070121customerservice@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606193382Overwatch PCF33073-0012026-07-30
00840606193399Overwatch PCF33073-0022026-07-30
00840606193405Overwatch PCF33073-0032026-07-30
00840606193412Overwatch PCF33073-0042026-07-30
00840606193429Overwatch PCF33074-0012026-07-30
00840606193436Overwatch PCF33074-0022026-07-30
00840606193443Overwatch PCF33074-0032026-07-30
00840606193450Overwatch PCF33074-0042026-07-30
00840606194044Overwatch PCF33077-0052026-07-30
00840606194051Overwatch PCF33077-0062026-07-30
00840606194068Overwatch PCF33077-0072026-07-30
00840606194075Overwatch PCF33077-0082026-07-30
00840606194082Overwatch PCF33077-0092026-07-30
00840606194099Overwatch PCF33077-0102026-07-30
00840606194105Overwatch PCF33077-0112026-07-30
00840606194112Overwatch PCF33077-0122026-07-30
00840606194129Overwatch PCF33077-0132026-07-30
00840606194136Overwatch PCF33077-0142026-07-30
00840606194143Overwatch PCF33077-0152026-07-30
00840606194150Overwatch PCF33077-0162026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195560Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195577Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195584Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195591Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195614Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195621Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195638Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195645Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195652Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925195REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925201REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925218REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925225REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925232REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925249REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
04054896090955VERTICALESilony Medical GmbHOLO2026-07-30
04054896090962VERTICALESilony Medical GmbHOLO2026-07-30
04054896090979VERTICALESilony Medical GmbHOLO2026-07-30
04054896090986VERTICALESilony Medical GmbHOLO2026-07-30
04054896090993VERTICALESilony Medical GmbHOLO2026-07-30
04054896091006VERTICALESilony Medical GmbHOLO2026-07-30
04054896091013VERTICALESilony Medical GmbHOLO2026-07-30
04054896091020VERTICALESilony Medical GmbHOLO2026-07-30
04054896091037VERTICALESilony Medical GmbHOLO2026-07-30
04054896091044VERTICALESilony Medical GmbHOLO2026-07-30
04054896091051VERTICALESilony Medical GmbHOLO2026-07-30