FDA.reportPublic FDA data

NA

Primary DI
04055207042502
Brand
NA
Company
Richard Wolf GmbH
Model
8436521
Catalog number
8436.521
Device description
CONCAVE CARTILAGE FILE WL 125MM W 6.25MM rough, reusable
Published
2022-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBHAccessories, arthroscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207042502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207042502040552070425024055207042502

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length125Millimeter
Width6.25Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207069226NA1006921006922026-03-12
04055207069257NA1006981006982026-03-12
04055207068243VERTEBRIS89250643892506432026-02-10
04055207069691NA8922090328922090322026-02-10
04055207069707NA8922090228922090222026-02-10
04055207069714NA8922090238922090232026-02-10
04055207069721NA8922090338922090332026-02-10
04055207069738NA89220922892209222026-02-10
04055207069745NA89220923892209232026-02-10
04055207069790NA8924084158924084152026-01-14
04055207069806NA8924084128924084122026-01-14
04055207069813NA8924084228924084222026-01-14
04055207069820NA8924084258924084252026-01-14
04055207069837NA8924089228924089222026-01-14
04055207069851NA8924089258924089252026-01-14
04055207036693POWER STICK M5/0899550000189955000012025-12-18
04055207000328NA20301052030.1052023-01-11
04055207067987VERTEBRIS8922012788922012782025-11-17
04055207067994VERTEBRIS8922020078922020072025-11-17
04055207068007VERTEBRIS8922020088922020082025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417918MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776417949MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776418267MillenniumAvalign Technologies, Inc.NBH2026-03-23
B382SD18129DK0Surgical DirectSurgical Direct, Inc.NBH2026-03-09
B382SD316590Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD316790Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD9156321000Surgical DirectSurgical Direct, Inc.NBH2026-02-26
00190776416386MillenniumAvalign Technologies, Inc.NBH2026-02-16
04055207068243VERTEBRISRichard Wolf GmbHNBH2026-02-10
04055207069691NARichard Wolf GmbHNBH2026-02-10
04055207069707NARichard Wolf GmbHNBH2026-02-10
04055207069714NARichard Wolf GmbHNBH2026-02-10
04055207069721NARichard Wolf GmbHNBH2026-02-10
04055207069738NARichard Wolf GmbHNBH2026-02-10
04055207069745NARichard Wolf GmbHNBH2026-02-10
B382SD181290Surgical DirectSurgical Direct, Inc.NBH2026-02-06
10748426142719Arthrex®Microtek Medical LLCNBH2026-02-02
07630542726620SportMeds InstrumentsMedacta International SANBH2026-01-30
00888867516144Arthrex®ARTHREX, INC.NBH2026-01-28
00888867516168Arthrex®ARTHREX, INC.NBH2026-01-28
07630542703683SportMeds InstrumentsMedacta International SANBH2026-01-21
00812231034170ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00812231034941ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00198506087622ELMED INCORPORATEDELMED INCORPORATEDNBH2026-01-16
04055207069790NARichard Wolf GmbHNBH2026-01-14
04055207069806NARichard Wolf GmbHNBH2026-01-14
04055207069813NARichard Wolf GmbHNBH2026-01-14
04055207069820NARichard Wolf GmbHNBH2026-01-14
04055207069837NARichard Wolf GmbHNBH2026-01-14
04055207069851NARichard Wolf GmbHNBH2026-01-14