FDA.report

ADSTATION OTO LED/OPH COAX LED W/SPEC

Primary DI
00733657274714
Brand
ADSTATION OTO LED/OPH COAX LED W/SPEC
Company
ALIMED, INC.
Model
938232
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HLJOphthalmoscope, battery-powered

Product Code Classifications

CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00733657274714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657274714007336572747147336572747140733657274714

GMDN Terms

TermDefinition
ENT cabinetA stand-alone, furniture-like device designed to store, display, and provide readily accessible for the operator the instruments, devices, and materials, including the local anaesthetics used in ear/nose/throat (ENT) treatments/procedures. This device is used in hospitals and physician's offices and will typically have a worktop intended to facilitate the intervention. The device may include features, e.g., suction and pressure pumps, fibreoptic-light source, built-in electrical outlets. It will have wheels for easy movement.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags

DUNS number
056007248
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00733657301038ATEC KIT 4 STRAPS96114529700181532024-08-02
00733657288667ATEC STRAP 2 X 84IN 2 CLOSURE PELVIC LONG96119629700182042024-08-02
00733657288674ATEC STRAP 2 X 72IN 2 CLOSURE PELVIC SHORT96119729700182052024-08-02
00733657288681ATEC STRAP 2 X 42IN 2 CLOSURE THORACIC96119829700182062024-08-02
00733657230253CUSH DROP AWAY POMMEL 16X168892429700113712022-12-15
00733657230260DROP AWAY POMMEL CUSHION 18X168892529700113722022-12-15
00733657240054CATH LAB IMMOBILIZER93189829700134112022-12-15
00733657245035STRAP UNIVERSAL UNIBODY, 5WX65L9-93129700188652022-12-15
00733657283594STRAP UNIVERSAL 3IN X 72IN 10/PK75361029700099892022-12-15
00733657283600STRAP UNIVERSAL 3IN X 72IN 25/PK62575362529700099912022-12-15
00733657283624STRAP UNIVERSAL 4IN x 72IN 10/PK75391029700099962022-12-15
00733657283631STRAP UNIVERSAL 4IN x 72IN 25/PK75392529700099982022-12-15
00733657283648STRAP UNIVERSAL 4IN x 72IN 50/PK75395029700099992022-12-15
00733657283662STRAP UNIVERSAL 4IN x 72IN 100/PK753910029700099972022-12-15
00733657290684ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS31716032022-12-01
00656204000201HARNESS PAVLIK TYPE51968/NA/LG2022-12-01
00656204000218HARNESS PAVLIK TYPE51968/NA/MD2022-12-01
00656204000225HARNESS PAVLIK TYPE51968/NA/SM2022-12-01
00656204000232HARNESS PAVLIK TYPE51968/NA/XL2022-12-01
00656204004940AFO CHILD LEFT66132/NA/LL2022-12-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
16972545090024JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-03
06972545090133JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-02
00732094357929Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-11-25
04053755202966BETA X OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2025-07-17
00732094357936Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
00732094357943Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
10193489136241MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-11-28
10193489136210MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-09-09
00810149097515R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-08-28
04053755202232K 180 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2024-06-27
00850038195335Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00850038195342Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00810149090684R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090745R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090837R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091056R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091148R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149092039R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093630R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093647R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094637R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094644R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00634782601669Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2023-12-15
04030155000392EUROLIGHT E30, 2.5V ophthalmoscope with clic-closureKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04030155001542BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscopeKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04053755120000BETA 200 S OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755120017K 180 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755119981BETA 200 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-12
00732094347074Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2022-08-05
00732094347081Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2022-08-05