FDA.report

Instrapac

Primary DI
05010058080386
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8038
Catalog number
8038
Device description
Instrapac Volkmann Spoon Double Ended 14cm X 20
Published
2025-05-21
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

Contact Domains

Product Codes

CodeName
HTFCurette

Product Code Classifications

CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058080386PackageGS120In Commercial Distribution
05010058999725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058080386050100580803865010058080386
05010058999725050100589997255010058999725

GMDN Terms

TermDefinition
Bone curette, single-useA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a single-use device.

Device Sizes

TypeValueUnit
Length14Centimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep dry and keep out of direct 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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00190776416669MillenniumAvalign Technologies, Inc.HTF2026-02-16
03662663109475Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
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00190776416041MillenniumAvalign Technologies, Inc.HTF2026-02-06
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00190776416065MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776415785MillenniumAvalign Technologies, Inc.HTF2026-02-04
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03662663083584ActivLHighridge Medical, LLCHTF2026-02-03
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