FDA.reportPublic FDA data

ELMED

Primary DI
00842180166820
Brand
ELMED
Company
ELMED INCORPORATED
Model
9825
Catalog number
9825
Device description
ELMED HALOGEN HEADLIGHT: INCLUDES; ADJUSTABLE HEADBAND, HALOGEN LAMP MIRROR SYSTEM AND SUPPLY CABLE
Published
2023-04-17
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
HPPHeadlamp, Operating, Battery-Operated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPPHeadlamp, Operating, Battery-OperatedOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842180166820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180166820008421801668208421801668200842180166820

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

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
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
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506089763ELMED INCORPORATED52460-01-H52460-01-H2026-03-24
00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
00198506089787ELMED INCORPORATED52460-03-H52460-03-H2026-03-24
00198506089756ELMED INCORPORATED42-191042-19102026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057147028963LYNXUNIVET LOUPES SPAHPP2026-03-02
08057147028970LYNX PROUNIVET LOUPES SPAHPP2026-03-02
00810186670214Enova IlluminationEnova Illumination, Inc.HPP2026-02-27
00860015454782RocotoRocoto Inc.HPP2026-02-26
00810186670146Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670153Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670160Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670177Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670184Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670191Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670207Enova IlluminationEnova Illumination, Inc.HPP2025-12-10
00810186670139Enova IlluminationEnova Illumination, Inc.HPP2025-08-18
00194613122683MSI Precision Specialty InstrumentsMed Saver, Inc.HPP2025-08-01
00194613122690MSI Precision Specialty InstrumentsMed Saver, Inc.HPP2025-08-01
00840183529680BR Surgical, LLCBR Surgical, LLCHPP2025-07-16
00840183529970BR Surgical, LLCBR Surgical, LLCHPP2025-07-16
00860014100680AmimonRocoto Inc.HPP2025-06-24
00850061395016RONINRonin Surgical Corp.HPP2025-06-06
00860013851545C3QED, INC.HPP2025-05-21
00860013851552Centauri 2QED, INC.HPP2025-05-21
00817157020832AmimonAMIMON LTDHPP2025-04-03
00840277406941MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406958MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406965MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406972MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406989MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277406996MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407009MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407016MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17
00840277407023MaxLite EliteRIVERPOINT MEDICAL, LLCHPP2024-12-17