FDA.reportPublic FDA data

Sterile,Single Use,Needle Holder,11mm Curved Jaws,Round Knurled Handle With Lock

Primary DI
05404027420844
Brand
Sterile,Single Use,Needle Holder,11mm Curved Jaws,Round Knurled Handle With Lock
Company
Hasa Optix
Model
552008
Published
2024-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
05404027420844PrimaryGS10
05404027406015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404027420844054040274208445404027420844
05404027406015054040274060155404027406015

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+32025246388info@hasaoptix.com

Regulatory Flags#

DUNS number
371290408
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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05404027449388Sub Tenon Set RaynerHA-SET0652025-06-12
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05404027419633Sterile,Single Use,Vitreoretinal Forceps,Gripping Forceps,RoundedTips,25G,145mm6560282024-07-22
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05404027449258Accord Cataract SetHA-SET0602025-02-21
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