FDA.report

Response 5.5/6.0 Cannulated Screw System

Primary DI
00840194417075
Brand
Response 5.5/6.0 Cannulated Screw System
Company
ORTHOPEDIATRICS CORP.
Model
01-1301-1060
Device description
5.5/6.0 6.0 Cannulated Tap (1.75mm Cannulation)
Published
2023-03-31
Public version status
New
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
HWXTAP, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840194417075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194417075008401944170758401944170750840194417075

GMDN Terms

TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
796416191
Device count
1
DM exempt
false
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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00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
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00840194499200Contracture ManagementNS-6000-3002NS-6000-30022026-03-02
00840194499217Contracture ManagementNS-6000-3003NS-6000-30032026-03-02
00840194499224Contracture ManagementNS-6000-3004NS-6000-30042026-03-02
00840194499231Contracture ManagementNS-6000-3005NS-6000-30052026-03-02
00840194499248Contracture ManagementNS-6000-4001NS-6000-40012026-03-02
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00840194498944Response 5.5/6.001-1300-607301-1300-60732026-01-15
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