FDA.reportPublic FDA data

PILLING

Primary DI
24026704507409
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN002379
Catalog number
070342
Device description
RING BLADE LEFT NUMBER 3
Published
2018-09-15
Public version status
New
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
04026704507405Direct MarkingGS10
24026704507409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704507405040267045074054026704507405
2402670450740924026704507409

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, non-adjustableA mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15.5Centimeter

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

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Primary DI, Brand, Company table
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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
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00757770406890Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
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00757770410620Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
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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