FDA.reportPublic FDA data

Symmetry Harms

Primary DI
00887482049280
Brand
Symmetry Harms
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
60-2421
Catalog number
60-2421
Device description
Symmetry® Trabeculotome, Harms Right
Published
2024-08-20
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
HNKProbe, Trabeculotomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNKProbe, TrabeculotomyOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482049280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482049280008874820492808874820492800887482049280

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue surgical forceps probe-tip, reusableA distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-888-364-7004customerservice@symmetrysurgical.com
+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
04547451338628Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451338635Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451338642Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-19
04547451336808Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2025-06-13
00840306824036Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
00840306824043Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
00840306824050Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HNK2025-01-17
04547451338062Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2024-10-07
00840343723910GEN2SURGIX MEDICAL LLCHNK2024-09-19
G586OP7135320Novo SurgicalNOVO SURGICAL, INC.HNK2023-12-18
G586OP7135330Novo SurgicalNOVO SURGICAL, INC.HNK2023-12-18
04547451332381Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451332398Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451332404Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335337Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335344Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
04547451335351Inami Ophthalmic InstrumentsINAMI & CO., LTD.HNK2023-10-26
00190776359508MillenniumAvalign Technologies, Inc.HNK2023-02-22
00841668128022HARMS TRABECULOTOMY PROBE RIGHTKATENA PRODUCTS, INC.HNK2022-12-07
00841668128039HARMS TRABECULOTOMY PROBE LEFTKATENA PRODUCTS, INC.HNK2022-12-07
04049368055662N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055693N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055938N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368055952N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368144908N.A.Geuder AktiengesellschaftHNK2021-07-05
04049368144915N.A.Geuder AktiengesellschaftHNK2021-07-05
00190660127343Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04
00190660127350Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04
00190660127367Ambler SurgicalAMBLER SURGICAL CORP.HNK2021-01-04
0081748902714123ga DEX™ Hassan ForcepsKATALYST SURGICAL LLCHNK2020-11-01