FDA.reportPublic FDA data

ELEVATOR

Primary DI
00888118062529
Brand
ELEVATOR
Company
KLS-Martin L.P.
Model
38-527-02-07
Device description
SINUS, LINDORF, RIGHT
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118062529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118062529008881180625298881180625290888118062529

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118149244L1 THORACICCTM-24-015-84-042026-05-01
00888118149251L1 CMFCTM-55-911-83-042026-05-01
00888118149268L1 CMFCTM-55-911-84-042026-05-01
00888118149275L1 CMFCTM-55-911-85-042026-05-01
00888118149282L1 CMFCTM-55-911-86-042026-05-01
00888118149299L1 CMFCTM-55-911-87-042026-05-01
00888118149305L1 CMFCTM-55-911-88-042026-05-01
00888118149312L1 CMFCTM-55-911-89-042026-05-01
00888118149329L1 CMFCTM-55-911-90-042026-05-01
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400583MillenniumAvalign Technologies, Inc.GEG2026-07-19
18257200087433ALIF DISC PREP,ALLOQUENT - ALIFOrthofix US LLCGEG2026-07-17
B382SD6216030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216060Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216080Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907037100T0Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD9070451100Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907075030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD92268003T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268030T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268031T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268032T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268033T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268034T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268035T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268036T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268037T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268038T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268039T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268040T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268041T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268042T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268043T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268044T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268045T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268046T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268047T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268048T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD9147091800Surgical DirectSurgical Direct, Inc.GEG2026-07-09
00850083275822Intrace USAPILOTIS TECH LLCGEG2026-07-03