FDA.reportPublic FDA data

PILLING

Primary DI
54026704808545
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN021632
Catalog number
P27608
Device description
MINNESOTA CHEEK RETRACTOR
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
KALRETRACTOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54026704808545Direct MarkingGS10
14026704808547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5402670480854554026704808545
1402670480854714026704808547

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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776416461MillenniumAvalign Technologies, Inc.KAL2026-02-16
00757770684304Bausch + LombBausch & Lomb IncorporatedKAL2025-08-05
00757770403011Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770412280Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770419425Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770419579Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770432486Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770414987Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770422050Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770423705Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770424603Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770428625Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
07899798208858QuinelatoSchobell Industrial LtdaKAL2025-02-27
00810123208395Adler Instrument CompanyAdler, Inc.KAL2025-01-27
00810123208203Adler Instrument CompanyAdler, Inc.KAL2025-01-10
00757770402526Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770402762Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405343Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405718Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405848Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770406890Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770409310Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770410620Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770413799Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770414079Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770414277Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770419371Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770419463Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420407Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420421Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21