FDA.reportPublic FDA data

ONE

Primary DI
03700483622627
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
275937506
Device count
1
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
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
00724995320041V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320058V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
00724995320065V. MuellerSTERIS Deutschland GmbHHNM2026-09-25
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