FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506093975
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
25657-10
Catalog number
25657-10
Device description
BARRAQUER-TROUTMAN, Needle Holder, Smooth, Curved, With Ratchet, 10cm (4")
Published
2026-08-18
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
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506093975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506093975001985060939751985060939750198506093975

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
00198506095863ELMED INCORPORATEDST129100ST1291002026-10-23
00198506096310ELMED INCORPORATED12-910012-91002026-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07612717072169FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072176FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072190FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
B382SD902769010Surgical DirectSurgical Direct, Inc.HNR2026-10-28
00724995266707Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266714Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266721Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266738Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266745Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266769Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266776Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266783Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995316280V. MuellerSTERIS Deutschland GmbHHNR2026-10-27
00190776437039MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437046MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437053MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776435721MillenniumAvalign Technologies, Inc.HNR2026-10-21
00190776435318MillenniumAvalign Technologies, Inc.HNR2026-10-19
G346EA32C0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-16
00190776434885MillenniumAvalign Technologies, Inc.HNR2026-10-14
00190776434984MillenniumAvalign Technologies, Inc.HNR2026-10-14
00192896123939Bishop Harmon Tissue ForcepsSONTEC INSTRUMENTS, INC.HNR2026-10-14
G346EA41VSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-14
00757770602506Bausch + LombBausch & Lomb IncorporatedHNR2026-10-09
00190776436209MillenniumAvalign Technologies, Inc.HNR2026-10-08
00190776433734MillenniumAvalign Technologies, Inc.HNR2026-10-07
00190776436155MillenniumAvalign Technologies, Inc.HNR2026-10-07
0081748902541323ga DEX™ Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07