FDA.reportPublic FDA data

Alira Medical Devices

Primary DI
G767GKR102A0
Brand
Alira Medical Devices
Company
Alira Medical Devices, LLC
Model
GKR-102A
Catalog number
GKR-102A
Device description
HARRINGTON RETRACTOR 8cm 5x10mm
Published
2025-07-17
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G767GKR102A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 818-614-4592info@alirameddevices.com

Regulatory Flags#

DUNS number
112837961
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G767AAA01510Alira Medical DevicesAAA-0151AAA-01512025-09-26
G767AAA03960Alira Medical DevicesAAA-0396AAA-03962025-09-26
G767ATSCA010T0Alira Medical DevicesATSC-A010TATSC-A010T2025-09-26
G767C024120Alira Medical DevicesC02-412C02-4122025-09-26
G767C024300Alira Medical DevicesC02-430C02-4302025-09-26
G767C025200Alira Medical DevicesC02-520C02-5202025-09-26
G767C02G4240Alira Medical DevicesC02G-424C02G-4242025-09-26
G767C171080Alira Medical DevicesC17-108C17-1082025-09-26
G767C174090Alira Medical DevicesC17-409C17-4092025-09-26
G767C174230Alira Medical DevicesC17-423C17-4232025-09-26
G767C174240Alira Medical DevicesC17-424C17-4242025-09-26
G767C174300Alira Medical DevicesC17-430C17-4302025-09-26
G767C17526E0Alira Medical DevicesC17-526EC17-526E2025-09-26
G767C175330Alira Medical DevicesC17-533C17-5332025-09-26
G767C214240Alira Medical DevicesC21-424C21-4242025-09-26
G767C21532A0Alira Medical DevicesC21-532AC21-532A2025-09-26
G767C21533A0Alira Medical DevicesC21-533AC21-533A2025-09-26
G767CBW1010Alira Medical DevicesCBW-101CBW-1012025-09-26
G767CCB1010Alira Medical DevicesCCB-101CCB-1012025-09-26
G767CCB1020Alira Medical DevicesCCB-102CCB-1022025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400620MillenniumAvalign Technologies, Inc.GAD2026-07-19
00190776400330MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400361MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400453MillenniumAvalign Technologies, Inc.GAD2026-07-17
00198506039072ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092152ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092190ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092206ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092213ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092220ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092237ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092244ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092251ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092268ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092275ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092282ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092299ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092305ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092312ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092329ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092336ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092626ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00810220800454Adler Instrument CompanyAdler, Inc.GAD2026-07-17
04058749048186NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749049800NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749078008NAFehling Instruments GmbH & Co. KGGAD2026-07-17
B382SD907808200Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD907808210Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD9079001010Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD97247105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-17