FDA.report

Instrapac

Primary DI
05010058182646
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8264
Catalog number
8264
Device description
Instrapac Olsen-Hegar Needle Holder 14cm x 50
Published
2025-06-23
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

Related Records

Product Codes

CodeName
GDFGuide, Needle, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058182646PackageGS150In Commercial Distribution
05010058082649PrimaryGS10

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length14Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep out of sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+441909735502ASKVCI@vernacare.com

Regulatory Flags

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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

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