FDA.reportPublic FDA data

DeGen Standard Instrumentation

Primary DI
00842048150398
Brand
DeGen Standard Instrumentation
Company
DEGEN MEDICAL, INC.
Model
97-62D0716L
Catalog number
97-62D0716L
Device description
Cervical Modular Rasp, 7H X 16X14
Published
2023-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842048150398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842048150398008420481503988420481503980842048150398

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)240-7838customerservice@degenmedical.com

Regulatory Flags#

DUNS number
078812602
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842048154976Solar™ Interbody Fusion System12-28M12-28M2024-10-07
00842048182276DeGen Standard Instrumentation97-68M97-68M2025-03-10
00842048181910Solar™ Interbody Fusion System12-89M12-89M2024-06-10
00842048150343Solar™ Interbody Fusion System12-14M12-14M2023-07-15
00842048152996Latitude-C Cervical Interbody Spacer System03-03M03-03M2022-08-22
00842048137559Impulse Interbody Spacer System07-06M07-06M2021-12-22
00842048182726Latitude-C AM™ Cervical Interbody Fusion System0306-161405L040306-161405L042025-11-24
00842048182733Latitude-C AM™ Cervical Interbody Fusion System0306-161406L040306-161406L042025-11-24
00842048182740Latitude-C AM™ Cervical Interbody Fusion System0306-161407L040306-161407L042025-11-24
00842048182757Latitude-C AM™ Cervical Interbody Fusion System0306-161408L040306-161408L042025-11-24
00842048182764Latitude-C AM™ Cervical Interbody Fusion System0306-161409L040306-161409L042025-11-24
00842048182771Latitude-C AM™ Cervical Interbody Fusion System0306-161410L040306-161410L042025-11-24
00842048182788Latitude-C AM™ Cervical Interbody Fusion System0306-161411L040306-161411L042025-11-24
00842048182795Latitude-C AM™ Cervical Interbody Fusion System0306-161412L040306-161412L042025-11-24
00842048182801Latitude-C AM™ Cervical Interbody Fusion System0306-161413L040306-161413L042025-11-24
00842048182818Latitude-C AM™ Cervical Interbody Fusion System0306-161414L040306-161414L042025-11-24
00842048182979Latitude-C AM™ Cervical Interbody Fusion System0306-181410L040306-181410L042025-11-24
00842048182986Latitude-C AM™ Cervical Interbody Fusion System0306-181411L040306-181411L042025-11-24
00842048182993Latitude-C AM™ Cervical Interbody Fusion System0306-181412L040306-181412L042025-11-24
00842048183006Latitude-C AM™ Cervical Interbody Fusion System0306-181413L040306-181413L042025-11-24

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