FDA.report

Diamatrix

Primary DI
00813059015488
Brand
Diamatrix
Company
Diamatrix
Model
N10-SL
Device description
Barraquer Needle Holder, Fine Delicate, Straight shaft, 10mm smooth jaws with pointed tips, With Lock, Diamond knurled handle, 135mm total length, Stainless.
Published
2019-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813059015488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059015488008130590154888130590154880813059015488

GMDN Terms

TermDefinition
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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
809555139
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00810163790379Inami & Co., Ltd.M-2220RM-2220R2025-05-20
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00810163790249Diamatrix Ltd.C276-21.3C276-21.32025-01-27
00810163790195Diamatrix Ltd.S106-CSS106-CS2024-12-12
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