FDA.reportPublic FDA data

Placement Wrench for LSB Bolts

Primary DI
00841823104397
Brand
Placement Wrench for LSB Bolts
Company
AD-TECH MEDICAL INSTRUMENT CORPORATION
Model
LSB-PWL-4.0-11N
Catalog number
LSB-PWL-4.0-11N
Published
2021-08-09
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
HXCWRENCH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841823104397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841823104397008418231043978418231043970841823104397

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags#

DUNS number
174813410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00841823110848Ad-Tech Macro Depth ElectrodeSR12R-SP05X-0BHSR12R-SP05X-0BH2026-02-23
00841823110855Ad-Tech Macro Depth ElectrodeSR08R-SP05X-0BHSR08R-SP05X-0BH2026-02-23
00841823110862Ad-Tech Macro Depth ElectrodeSR08R-SP21X-0C3SR08R-SP21X-0C32026-02-23
00841823110879Ad-Tech Macro Depth ElectrodeSR08R-SP61X-0C3SR08R-SP61X-0C32026-02-23
00841823110886Ad-Tech Macro Depth ElectrodeSR10R-SP05X-0BHSR10R-SP05X-0BH2026-02-23
00841823110893Ad-Tech Macro Depth ElectrodeSR10R-SP21X-0C3SR10R-SP21X-0C32026-02-23
00841823110909Ad-Tech Macro Depth ElectrodeSR10R-SP61X-0C3SR10R-SP61X-0C32026-02-23
00841823110916Ad-Tech Macro Depth ElectrodeSR12R-SP21X-0C3SR12R-SP21X-0C32026-02-23
00841823110923Ad-Tech Macro Depth ElectrodeSR12R-SP61X-0C3SR12R-SP61X-0C32026-02-23
00841823109996SIGNUM Connection System Cable1L-JBL-2DIN2025-12-09
00841823110008SIGNUM Connection System Cable1L-JBL-4DIN2025-12-09
00841823110015SIGNUM Connection System Cable1L-JBL-6DIN2025-12-09
00841823110039SIGNUM Connection System Cable1L-JBL-8DIN2025-12-09
00841823110053SIGNUM Connection System Cable1L-JBL-10DIN2025-12-09
00841823110060SIGNUM Connection System Cable1L-JBL-12BDIN2025-12-09
00841823110077SIGNUM Connection System Cable1L-JBL-14BDIN2025-12-09
00841823110084SIGNUM Connection System Cable1L-JBL-16DIN2025-12-09
00841823110091SIGNUM Connection System Cable1L-JBL-16BDIN2025-12-09
00841823110107SIGNUM Connection System Cable1L-JBL-20DIN2025-12-09
00841823110114SIGNUM Connection System Cable1L-JBL-24BDIN2025-12-09

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