FDA.reportPublic FDA data

PILLING

Primary DI
54026704802925
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN020745
Catalog number
P25784
Device description
RET TESSIER MALLEABLE 15/17MM 8.75"
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
EIGRETRACTOR, ALL TYPES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54026704802925Direct MarkingGS10
14026704802927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670480292554026704802925
1402670480292714026704802927

GMDN Terms#

Term, Definition table
TermDefinition
Dental cheek retractor, professional, reusableA hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). 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
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
08961104622197Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622203Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622210Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622227Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622234Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622241Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622258Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622265Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622272Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622289Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
10304040196998Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197001Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197018Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
00348783010220Premier RetractorsPREMIER DENTAL PRODUCTS COMPANYEIG2026-05-06
G149NP260020NPSACME ENTERPRISE.EIG2026-05-01
G149NPORR0NPSACME ENTERPRISE.EIG2026-05-01
00371347023459Advance Dental ProductsThe Atlanta Dental Supply CompanyEIG2026-04-14
B382SD9144082080Surgical DirectSurgical Direct, Inc.EIG2026-02-12
B382SD9210921010Surgical DirectSurgical Direct, Inc.EIG2026-02-12
00841336128828Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIG2025-11-04
00190707191153Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
00190707191160Ortho Technology®Ortho Organizers, Inc.EIG2025-10-23
B382SD5615280Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640120Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640140Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640160Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640180Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640200Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640220Surgical DirectSurgical Direct, Inc.EIG2025-10-06
B382SD5640300Surgical DirectSurgical Direct, Inc.EIG2025-10-06