FDA.report

Placement Wrench for LSB Bolts

Primary DI
00841823104366
Brand
Placement Wrench for LSB Bolts
Company
AD-TECH MEDICAL INSTRUMENT CORPORATION
Model
LSB-PWL-2.4-10X
Catalog number
LSB-PWL-2.4-10X
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
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXCWRENCH

Product Code Classifications

CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841823104366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841823104366008418231043668418231043660841823104366

GMDN Terms

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

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

Sterilization Methods

Method

Contacts

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
false

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