FDA.reportPublic FDA data

INKA

Primary DI
09348811101655
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
30522.19
Device description
LEMPERT Periosteal Elevator sharp 19cm
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KADElevator, Ent

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348811101655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348811101655093488111016559348811101655

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
742109993
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348811083098INKA20706.182026-07-31
09348811100542INKA30258.002026-07-31
09348811102645INKA31351.172026-07-31
09348811102669INKA31352.172026-07-31
09348811103291INKA36429.052026-07-31
09348811109194INKA31278.162026-07-31
09348811111951INKA31252.122026-07-31
09348811111982INKA31255.042026-07-31
09348811112026INKA31255.152026-07-31
09348811114846INKA31657.132026-07-31
09348811150257INKA31287.20 RD2026-07-31
09348811155320INKA31255.032026-07-31
09348811155337INKA31255.122026-07-31
09348811109798INKA30370.192026-07-30
09348811149756INKA31254.062026-07-30
09348811146069INKA33343.202026-07-03
09348811022066INKA31654.082026-06-02
09348811105868INKA31740.082026-06-02
09348811111944INKA31252.102026-06-02
09348811115461INKA36187.132026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462911462evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911479evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911486evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911493evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911936evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911943evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911950evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911967evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911998evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912001evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912018evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912032evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912674evonosevonos GmbH & Co. KGKAD2026-08-19
04054462907373evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907403evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907410evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907427evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907434evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907458evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907465evonosevonos GmbH & Co. KGKAD2026-08-18
00757770683567Bausch + LombBausch & Lomb IncorporatedKAD2026-05-11
09348811102522INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811101433INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-03-18
04046826112790MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAD2026-03-04
00190776415945MillenniumAvalign Technologies, Inc.KAD2026-02-06
00757770425143Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
00757770636822Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
09348811101587INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-28
00810207783039Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783046Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24