FDA.reportPublic FDA data

PILLING

Primary DI
14026704803016
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN020763
Catalog number
P25834
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMMCHISEL, OSTEOTOME, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54026704803014Direct MarkingGS10
14026704803016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670480301454026704803014
1402670480301614026704803016

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESAM13290011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333061STOMA®Storz am Mark GmbHEMM2020-08-27
10649111069406Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111069710Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111069765Sklar®SKLAR CORPORATIONEMM2018-10-22
10649111070082Sklar®SKLAR CORPORATIONEMM2018-10-22