FDA.reportPublic FDA data

ONE

Primary DI
03700483612666
Brand
ONE
Company
MORIA SA
Model
ONE S-Needle holder X5
Catalog number
17534X5
Published
2023-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700483622627PackageGS15In Commercial Distribution
03700483612666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483622627037004836226273700483622627
03700483612666037004836126663700483612666

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. This is a single-use device.

Regulatory Flags#

DUNS number
275937506
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700483630219MORIADUAL ACTION SINSKEY MANIPULATOR200672026-09-25
03700483630240MORIADUAL ACTION CURVED SCRAPER200682026-09-25
00370048360849MORIAEPI-K REUSABLE SUCTION RING 019389/02026-07-20
03700483600397MORIAM2SU 130 HEAD19334/1302026-07-20
03700483600410MORIAM2SU 90 HEAD19334/902026-07-20
03700483600557MORIAEPI-K SET (-1 RING)193842026-07-20
03700483600571MORIAEpi-K Head193902026-07-20
03700483608416MORIAEPI-K HANDPIECE193422026-07-20
03700483608485MORIAEPI-K REUSABLE SUCTION RING -119389/-12026-07-20
03700483608553MORIAEPI-K LD REUSABLE SUCTION RING -119399/-12026-07-20
03700483628179MORIARADIAL MARKER 8 BLADES20148/82026-07-16
03700483628209MORIARADIAL MARKER 16 BLADES20148/162026-07-16
03700483628261MORIARADIAL MARKER 12 BLADES20148/122026-07-16
03700483600243MORIAEvolution 2-3-3E tubing x10191382023-12-27
03700483630479MORIAGoosey Forceps190902026-04-21
03700483603206MORIAOU LC 250 HEAD ARTIFICIAL CHAMBER19184/2502024-05-07
03700483601974MORIACBSU 50 HEAD - ART. CHAMBER19178/502024-05-07
03700483602032MORIACBSU 130 HEAD - ART. CHAMBER19178/1302024-05-07
03700483602094MORIACBSU 110 HEAD - ART. CHAMBER19178/1102024-05-07
03700483602100MORIACBSU 250 HEAD - ART. CHAMBER19178/2502024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995295578V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
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00724995320072V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320089V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320096V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320102V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320119V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320126V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320133V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320140V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320157V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320171V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320188V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320201V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320218V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320225V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320270V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320287V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320294V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320300V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
G346EEN008Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2026-04-20
08800268430111LYNKS Frontalis SlingLynk Solutec Inc.HNM2026-03-03
G346EEN0132Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-12-17
04058935011574Osher Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011581Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011598Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011604Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011611Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10