FDA.reportPublic FDA data

25ga DEX™ Morris ILM Forceps

Primary DI
10817489025427
Brand
25ga DEX™ Morris ILM Forceps
Company
KATALYST SURGICAL LLC
Model
DVF4033-25
Catalog number
DVF4033-25
Device description
Box of 5, 25ga DEX™ Morris ILM Forceps
Published
2017-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
10817489025427PrimaryGS10
00817489025420Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081748902542710817489025427
00817489025420008174890254208174890254200817489025420

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, single-useA sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small jaw-like grasping blades that protrude from the distal end of the shaft. This is a single-use device.

Regulatory Flags#

DUNS number
007883297
Device count
5
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
1081748902630125ga DEX™ Slim Morris ILM ForcepsDVFO4033-25DVFO4033-252020-09-21
1081748902631827ga DEX™ Stiff Slim Morris ILM ForcepsDVFO4033-27DVFO4033-272020-09-21
1081748902714823ga DEX™ Hassan ForcepsDVF4035-23DVF4035-232020-11-01
1081748902716227ga DEX Stiff Hassan ForcepsDVF4035-27DVF4035-272020-11-01
1081748902731523ga Slim DEX™ Hassan ForcepsDVFO4035-23DVFO4035-232020-09-21
1081748902732225ga Slim DEX™ Hassan ForcepsDVFO4035-25DVFO4035-252020-09-21
1081748902733927ga Stiff Slim DEX™ Hassan ForcepsDVFO4035-27DVFO4035-272020-09-21
1081748902735327ga Slim DEX™ Vertical ScissorsDVSO5101-272020-11-01
1081748902739123ga MultiFlex Laser Probe, Iridex CompatibleXLEND23MULTIFLEXAXLEND23MULTIFLEXA2018-11-26
1084009621104423ga Slim DEX™ Super Grip II ForcepsDVFO4036-23DVFO4036-232020-09-21
1084009621110525ga Slim DEX™ Super Grip II ForcepsDVFO4036-25DVFO4036-252020-09-21
1084009621111227ga Stiff Slim DEX™ Super Grip II ForcepsDVFO4036-27DVFO4036-272020-09-21
1084009621117425ga Stiff DEX™ Yoneda Super Grip ForcepsDVF4036-25-SDVF4036-25-S2020-11-01
1084009621289823ga DEX™ EZPeel ForcepsDVF4037-23DVF4037-232020-07-06
1084009621290425ga DEX™ EZPeel ForcepsDVF4037-25DVF4037-252020-07-06
1084009621291127ga DEX™ EZPeel ForcepsDVF4037-27DVF4037-272020-07-06
1084009621292825ga Stiff DEX™ EZPeel ForcepsDVF4037-25-SDVF4037-25-S2020-07-06
1084009621293523ga Slim DEX™ EZPeel ForcepsDVFO4037-23DVFO4037-232020-07-06
1084009621294225ga Slim DEX™ EZPeel ForcepsDVFO4037-25DVFO4037-252020-07-06
1084009621295925ga Slim Stiff DEX™ EZPeel ForcepsDVFO4037-25-SDVFO4037-25-S2020-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776419721MillenniumAvalign Technologies, Inc.HNK2026-08-25
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
00887482049280Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNK2024-08-20
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