FDA.reportPublic FDA data

Placement Wrench for LSB Bolts

Primary DI
00841823108517
Brand
Placement Wrench for LSB Bolts
Company
Ad-Tech Medical Instrument Corporation
Model
LSB-PWL-2.0-11N
Catalog number
LSB-PWL-2.0-11N
Published
2021-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00841823108517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841823108517008418231085178418231085170841823108517

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841823108814Anchor Bolt Kit, LSB StyleLSBK1-AX-05LSBK1-AX-052026-04-08
00841823108821Anchor Bolt Kit, LSB StyleLSBK1-BX-05LSBK1-BX-052023-08-28
00841823108838Anchor Bolt Kit, LSB StyleLSBK1-CX-04LSBK1-CX-042023-08-28
00841823108845Anchor Bolt Kit, LSB StyleLSBK1-CX-05LSBK1-CX-052023-08-28
00841823108852Anchor Bolt Kit, LSB StyleLSBK2-AX-04LSBK2-AX-042023-08-28
00841823108869Anchor Bolt Kit, LSB StyleLSBK2-BX-04LSBK2-BX-042023-08-28
00841823109521Anchor Bolt Kit, LSB StyleLSBK1-CX-06LSBK1-CX-062023-08-28
00841823109538Anchor Bolt Kit, LSB StyleLSBK1-BX-06LSBK1-BX-062023-08-28
00841823109545Anchor Bolt Kit, LSB StyleLSBK1-AX-06LSBK1-AX-062023-08-28
00841823101228Subdural ElectrodeDG20A-SP07X-UPBDG20A-SP07X-UPB2016-09-23
00841823101235Subdural ElectrodeDG20A-SP10X-G00DG20A-SP10X-G002016-09-23
00841823101242Subdural ElectrodeDG20A-SP10X-GE2DG20A-SP10X-GE22016-09-23
00841823101259Subdural ElectrodeDG20A-SP10X-T00DG20A-SP10X-T002016-09-23
00841823101266Subdural ElectrodeDG20A-SP10X-U00DG20A-SP10X-U002016-09-23
00841823101273Subdural ElectrodeDG20A-SP10X-UE2DG20A-SP10X-UE22016-09-23
00841823101280Subdural ElectrodeDG24A-SP10X-000DG24A-SP10X-0002016-09-23
00841823101297Subdural ElectrodeDG24A-SP10X-G00DG24A-SP10X-G002016-09-23
00841823101303Subdural ElectrodeDG32A-SP10X-U00DG32A-SP10X-U002016-09-23
00841823101310Subdural ElectrodeDG32A-SP10X-V00DG32A-SP10X-V002016-09-23
00841823101327Subdural ElectrodeDG48B-SP10X-G00DG48B-SP10X-G002016-09-23

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