FDA.reportPublic FDA data

Needle Holder

Primary DI
00883475651362
Brand
Needle Holder
Company
CHARMANT INC.
Model
37-0008
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00883475651362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883475651362008834756513628834756513620883475651362

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It 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. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
693742728
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883475708523Multi Purpose Forceps37-00352023-09-18
00883475953930Paddle tip Manipulator37-00802023-09-18
00883475953947Ball tip Manipulator37-00812023-09-18
00883475953299MS Round-Crescent-Flat22-01BNJP2024-08-01
00883475953305MS Round-Crescent-Flat22-01BNKP2024-08-01
00883475953312MS Round-ST-Flat22-02BNIP2024-08-01
00883475953329MS Round-ST-Flat22-02BNKP2024-08-01
00883475953411MS Round-ST-CV22-03BNIP2024-08-01
00883475953428MS Round-ST-CV22-03BNKP2024-08-01
00883475951370Pressure Adjustable Micro-Sucker 7S31-50572023-09-18
00883475651300IOL Hook37-00022023-09-18
00883475651324Capsulorrhexis Forceps37-00042023-09-18
00883475651331Micro Scissors(Acute tips)37-00052023-09-18
00883475651348Micro Scissors(Blunt tips)37-00062023-09-18
00883475651355Iris Forceps37-00072023-09-18
00883475651379Wire Speculum37-00092023-09-18
00883475651386Wire Speculum with Blade37-00102023-09-18
00883475679038Micro Forceps CROSS MAX37-00112023-09-18
00883475679045Cilia Forceps CROSS MAX37-00122023-09-18
00883475679052Needle Holder(Thin tips)37-00132023-09-18

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