FDA.reportPublic FDA data

PINNACLE GRIPTION TF

Primary DI
10603295098461
Brand
PINNACLE GRIPTION TF
Company
DEPUY (IRELAND)
Model
2217-10-554
Catalog number
221710554
Device description
PINNACLE GRIPTION TF AUGMENT FIN RASP 54 x 10
Published
2018-09-24
Public version status
Update
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
HXCWRENCH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295098461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329509846110603295098461

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(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295085980GLOBAL UNITE2100-70-2502100702502018-06-15
10603295088196GLOBAL ADVANTAGE2128-02-0502128020502018-09-24
10603295130192ATTUNE2544-01-0032544010032018-09-24
10603295130208ATTUNE2544-01-0042544010042018-09-24
10603295130222ATTUNE2544-01-0062544010062018-09-24
10603295395423ATTUNE2544-01-0092544010092018-09-24
10603295431275DEPUY REACH9505-05-1349505051342018-09-24
10603295431596DEPUY REACH9505-05-1359505051352018-09-24
10603295440222ATTUNE2546-00-4242546004242016-12-05
10603295443780ATTUNE2544-91-0012544910012020-06-11
10603295443797ATTUNE2544-91-0022544910022020-06-11
10603295443803ATTUNE2544-91-0032544910032020-06-11
10603295443810ATTUNE2544-91-0042544910042020-06-11
10603295451297ATTUNE2546-00-4162546004162016-12-05
10603295493549ATTUNE2544-11-0032544110032017-04-10
10603295496229ATTUNE2546-00-5162546005162018-01-24
10603295543879RECLAIM74-1000-1157410001152026-01-23
10603295543916RECLAIM74-1000-1207410001202026-01-23
10603295503309ATTUNE1506-61-3101506613102026-01-13
10603295503316ATTUNE1506-61-3201506613202026-01-13

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