FDA.reportPublic FDA data

PILLING

Primary DI
54026704792226
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN017911
Catalog number
P16368
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
FXESPECULUM, NON-ILLUMINATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXESpeculum, Non-IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54026704792226Direct MarkingGS10
14026704792228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670479222654026704792226
1402670479222814026704792228

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. 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
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
00810158218888PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218895PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218901PRINCETONPrinceton Medical Group, Inc.FXE2026-02-16
00810158218178PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218185PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00810158218192PRINCETONPrinceton Medical Group, Inc.FXE2025-12-15
00194613065607MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613104726MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00194613120290MSI Precision Specialty InstrumentsMed Saver, Inc.FXE2025-08-01
00810158214699PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00810158214705PRINCETONPrinceton Medical Group, Inc.FXE2025-03-31
00192896100671TEALES GORGET SPECULUMSONTEC INSTRUMENTS, INC.FXE2025-02-24
00190776390167MillenniumAvalign Technologies, Inc.FXE2024-05-31
G586N6867570Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867580Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867590Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
G586N6867610Novo SurgicalNOVO SURGICAL, INC.FXE2023-12-18
00190776041786AvalignAvalign Technologies, Inc.FXE2023-11-13
00192896115750Teales Gorget SpeculumSONTEC INSTRUMENTS, INC.FXE2023-11-03
00190776316471MILLENNIUMAvalign Technologies, Inc.FXE2023-09-28
G453333611190PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
G4533336204900PEAK MEDICALPeak Medical Distribution Inc.FXE2023-09-12
00842962137956HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137963HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962137970HNM MEDICALHNM STAINLESS, LLC.FXE2023-04-02
00842962119150HNM MEDICALHNM STAINLESS, LLC.FXE2023-03-30
14026704792211PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
14026704792228PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
54026704792219PILLINGTELEFLEX INCORPORATEDFXE2022-12-08
00842331180996Novo Surgical Inc. NOVO SURGICAL, INC.FXE2022-11-14