FDA.reportPublic FDA data

Symmetry Kuglen

Primary DI
00887482040614
Brand
Symmetry Kuglen
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
60-1313
Catalog number
60-1313
Device description
Symmetry® Cannula, Kuglen Iris Hook & Lens Manipulator, Blunt, 0.5 mm Hook, Straight Shaft, 4 3/4 in, 120 mm
Published
2022-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482040614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482040614008874820406148874820406140887482040614

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/emergency suction cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4.75Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
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
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773729644IRIS RETRACTOR 5 HOOKSFCI S A S FCI 20 22HNQ2026-07-09
00757770451531Bausch + LombBausch & Lomb IncorporatedHNQ2026-06-22
04251047903076Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047903359Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047904745Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047925849Vera Fixation HookA1 Medical GmbHHNQ2026-05-29
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776420093MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776419912MillenniumAvalign Technologies, Inc.HNQ2026-04-15
00190776414214MillenniumAvalign Technologies, Inc.HNQ2025-10-22
00810163790447Diamatrix Ltd.DiamatrixHNQ2025-10-21
00810163790454Diamatrix Ltd.DiamatrixHNQ2025-10-21
00190776412616MillenniumAvalign Technologies, Inc.HNQ2025-10-03
00190776412005MillenniumAvalign Technologies, Inc.HNQ2025-10-01
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00810163790331Diamatrix Ltd.DiamatrixHNQ2025-05-27
10649111487934Sklar InstrumentsSKLAR CORPORATIONHNQ2025-01-03
0084009621513727ga Dunn/Rice ILM Pick, Carbon Fiber Handle, BluntKATALYST SURGICAL LLCHNQ2023-10-16
G2231196710Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-09-19
00810123480883Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480890Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480906Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480913Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
G2231196700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-01-12
14026704790675PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08