FDA.report

Adler Instrument Company

Primary DI
00810123200054
Brand
Adler Instrument Company
Company
Adler, Inc.
Model
AD62.7720
Device description
bone file/rasp 8.5" 18mm fine/
Published
2023-03-06
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

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810123200054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810123200054008101232000548101232000540810123200054

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
830141235
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
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

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00810123209996Adler Instrument Company46-8522026-03-17
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00810123209873Adler Instrument Company32-55052026-03-03
00810123209880Adler Instrument Company32-55062026-03-03
00810123209897Adler Instrument Company32-55072026-03-03
00810123209903Adler Instrument Company32-55082026-03-03
00810123209910Adler Instrument Company32-55092026-03-03
00810123209927Adler Instrument Company70-04552026-03-03
00810123209934Adler Instrument CompanyAD11-10032026-03-03
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00810123209958Adler Instrument Company200-2832026-03-03
00810123209965Adler Instrument Company30-03152026-03-03
00810123209972Adler Instrument CompanyAD21-23052026-03-03

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