FDA.reportPublic FDA data

ELMED

Primary DI
00842180188617
Brand
ELMED
Company
ELMED INCORPORATED
Model
49315-10
Catalog number
49315-10
Device description
GAG ONLY, KILNER-DOUGHTY
Published
2024-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00842180188617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180188617008421801886178421801886170842180188617

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, adjustable, reusableA mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506091155ELMED INCORPORATED37-5006-10ST37-5006-10ST2026-06-03
00198506091162ELMED INCORPORATED37-1010137-101012026-06-03
00198506091179ELMED INCORPORATEDSTE287850STE2878502026-06-03
00198506091186ELMED INCORPORATED37-013837-01382026-06-03
00198506091193ELMED INCORPORATED37-013937-01392026-06-03
00198506091209ELMED INCORPORATEDSTE1121040STE11210402026-06-03
00198506091216ELMED INCORPORATEDSTE3321924STE33219242026-06-03
00198506091223ELMED INCORPORATED42-242042-24202026-06-03
00198506091230ELMED INCORPORATEDSM13443-21-CRSM13443-21-CR2026-06-03
00198506091247ELMED INCORPORATED52125-7952125-792026-06-03
00198506091254ELMED INCORPORATED52105-61-0552105-61-052026-06-03
00198506091261ELMED INCORPORATED5990M255990M252026-06-03
00842180192515ELMEDST180831ST1808312024-04-10
00842180167766ELMED18-083118-08312023-04-21
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091155ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091162ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091186ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091193ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091223ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
14250368820892Soft CliP HookHeinz Kurz GmbHLRC2026-05-21
14250368861437Trocar HandleHeinz Kurz GmbHLRC2026-05-21
14250368862007Cartilage PunchHeinz Kurz GmbHLRC2026-05-21
00198506090790ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-15
00198506090752ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00198506090769ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00190776421366MillenniumAvalign Technologies, Inc.LRC2026-05-05
00198506090479ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-05
00190776420758MillenniumAvalign Technologies, Inc.LRC2026-04-30
00190776420871MillenniumAvalign Technologies, Inc.LRC2026-04-30
00198506090387ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00198506090394ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00757770535620Bausch + LombBausch & Lomb IncorporatedLRC2026-04-30
00198506090318ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-28
00198506090257ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00198506090288ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00190776419950MillenniumAvalign Technologies, Inc.LRC2026-04-15
00190776419578MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776419585MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776418977MillenniumAvalign Technologies, Inc.LRC2026-04-13
00198506089954ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-03
00198506089497ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089824ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089886ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02
00198506089909ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02