FDA.reportPublic FDA data

PILLING

Primary DI
54026704790871
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN055986
Catalog number
P14410
Device description
GOUGE ALEXANDER 4MM 7"
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54026704790871Direct MarkingGS10
14026704790873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670479087154026704790871
1402670479087314026704790873

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gougeA heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407544MillenniumAvalign Technologies, Inc.GDH2026-08-03
00190776407353MillenniumAvalign Technologies, Inc.GDH2026-07-28
B7685674460Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2026-04-24
B7685676080Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2026-04-24
B7685677060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2026-04-24
B7685676050Buxton BiomedicalBUXTON BIOMEDICAL, INC.GDH2023-12-08
B7685674210Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2023-06-16
B7687720200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2023-05-26
B7687722250Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDH2023-05-26
07898506847549QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848232QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848249QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848287QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848294QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848317QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848324QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506850259QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848256QuinelatoSchobell Industrial LtdaGDH2022-12-16
07898506848263QuinelatoSchobell Industrial LtdaGDH2022-12-16
04038653109999AESCULAPAesculap AGGDH2020-05-08
04038653110018AESCULAPAesculap AGGDH2020-05-08
04038653110056AESCULAPAesculap AGGDH2020-05-06
10603295083375SIGMADEPUY (IRELAND)GDH2018-09-24
10381780184584Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780184607Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780221128Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780363071Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780405603Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780403357Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403364Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03