FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506093777
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
41295-14-19
Catalog number
41295-14-19
Device description
FRAZIER/FERGUSSON SUCTION TUBE, 30 DEG, 14FR X 7-1/2" (19CM) WL
Published
2026-07-29
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506093777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506093777001985060937771985060937770198506093777

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, reusableA collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain 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
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18
00198506094064ELMED INCORPORATEDSTE6181010STE61810102026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426637MillenniumAvalign Technologies, Inc.LRC2026-08-19
00190776426347MillenniumAvalign Technologies, Inc.LRC2026-08-18
00844505014786FEATHERVAC, ECLIPSEGrace Medical, Inc.LRC2026-08-18
00844505014793FEATHERVAC, ECLIPSE FLAT RIBBONGrace Medical, Inc.LRC2026-08-18
04054462901142evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901159evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901166evonosevonos GmbH & Co. KGLRC2026-08-18
04054462901180evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902170evonosevonos GmbH & Co. KGLRC2026-08-18
04054462902187evonosevonos GmbH & Co. KGLRC2026-08-18
00190776423704MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423711MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776423728MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424374MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424381MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776424398MillenniumAvalign Technologies, Inc.LRC2026-08-07
00190776422653MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422660MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422684MillenniumAvalign Technologies, Inc.LRC2026-08-03
00190776422462MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422523MillenniumAvalign Technologies, Inc.LRC2026-07-31
00190776422585MillenniumAvalign Technologies, Inc.LRC2026-07-31
09348811102645INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
09348811102669INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-07-31
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321070Surgical DirectSurgical Direct, Inc.LRC2026-07-29