FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506092022
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST35165020
Catalog number
ST35165020
Device description
Flieringa Fixation Ring, 20mm
Published
2026-07-27
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
HOECaliper, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506092022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506092022001985060920221985060920220198506092022

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical procedure kit, non-medicated, reusableA collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
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
00198506056529ELMED INCORPORATEDSTT9920FSANSTT9920FSAN2026-10-16
00198506096075ELMED INCORPORATEDSTT9931FSANTSTT9931FSANT2026-10-16
00198506096082ELMED INCORPORATEDSTT9924FSANSTT9924FSAN2026-10-16
00198506096099ELMED INCORPORATEDST9932FSANTSTT9932FSANT2026-10-16
00198506095757ELMED INCORPORATEDST511740ST5117402026-10-09
00198506095764ELMED INCORPORATEDST7162700ST71627002026-10-09
00198506095771ELMED INCORPORATEDST233698ST2336982026-10-09
00198506095788ELMED INCORPORATEDST238248ST2382482026-10-09
00198506095795ELMED INCORPORATEDST365720ST3657202026-10-09
00198506095801ELMED INCORPORATEDST307060ST3070602026-10-09
00198506095818ELMED INCORPORATEDST307061ST3070612026-10-09
00198506095825ELMED INCORPORATEDST307062ST3070622026-10-09
00198506095832ELMED INCORPORATEDST307063ST3070632026-10-09
00198506095849ELMED INCORPORATEDST186403612ST1864036122026-10-09
00198506095856ELMED INCORPORATEDST1580095ST15800952026-10-09
00198506095870ELMED INCORPORATEDST33694-01ST33694-012026-10-09
00198506095887ELMED INCORPORATEDST7141014ST71410142026-10-09
00198506095894ELMED INCORPORATEDST7141015ST71410152026-10-09
00198506095900ELMED INCORPORATEDST7141016ST71410162026-10-09
00198506095917ELMED INCORPORATEDST7141017ST71410172026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995269210Snowden-PencerSTERIS Deutschland GmbHHOE2026-09-25
00724995269227Snowden-PencerSTERIS Deutschland GmbHHOE2026-09-25
00724995269234Snowden-PencerSTERIS Deutschland GmbHHOE2026-09-25
00724995318109V. MuellerSTERIS Deutschland GmbHHOE2026-09-25
00198506092619ELMED INCORPORATEDELMED INCORPORATEDHOE2026-07-28
00850083275891Intrace USAPILOTIS TECH LLCHOE2026-07-03
04251047924378Castroviejo CaliperA1 Medical GmbHHOE2026-05-29
00198506089053ELMED INCORPORATEDELMED INCORPORATEDHOE2026-03-03
00852194002090HAI CaliperHightech American Industrial Labs IncHOE2025-12-16
09348811124524INKAThe Trustee for KAISER FAMILY TRUSTHOE2025-11-28
00810207782575Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00810207782582Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00194613007409MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007423MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007430MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007454MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007508MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613051952MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613112783MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
04058935011055Castroviejo CaliperBausch & Lomb GmbHHOE2025-07-10
04058935011062Castroviejo Marking CaliperBausch & Lomb GmbHHOE2025-07-10
G412PH94030MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH94071T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH9408T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G2231113910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOE2025-06-04
G412PH20330MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH61270MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62500MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62510MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62520MR PHACOCrestpoint Management LimitedHOE2025-05-27