FDA.report

RESPONSE 5.5/6.0 Spine System

Primary DI
00841132136607
Brand
RESPONSE 5.5/6.0 Spine System
Company
ORTHOPEDIATRICS CORP.
Model
01-1300-4060
Catalog number
01-1300-4060
Device description
FireFly Tap, 6.0mm
Published
2017-02-15
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

Contact Domains

Product Codes

CodeName
HWXTAP, BONE

Product Code Classifications

CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841132136607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132136607008411321366078411321366070841132136607

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(574)268-6379Rbremer@orthopediatrics.com

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
false

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00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
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00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
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00840194498975Response 5.5/6.001-1300-935001-1300-93502026-03-03
00840194498982Response 5.5/6.001-1300-936001-1300-93602026-03-03
00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
00840536800251Response 5.5/6.001-1300-913601-1300-91362026-03-03
00840194499194Contracture ManagementNS-6000-3001NS-6000-30012026-03-02
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

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