FDA.report

Bone Screws

Primary DI
00841132136348
Brand
Bone Screws
Company
ORTHOPEDIATRICS CORP.
Model
44-0099-0035
Catalog number
44-0099-0035
Device description
MODULAR SCREW CADDY, 3.5MM
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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841132136348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132136348008411321363488411321363480841132136348

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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00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
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00840194499279Contracture ManagementNS-6000-4102NS-6000-41022026-03-02
00840194498968Response Spine System01-1600-559001-1600-55902026-01-29
00840194498128Response Spine System01-1300-091001-1300-09102026-01-22
00840194498043Response Spine System01-1300-551601-1300-55162026-01-15
00840194498050Response Spine System01-1300-551701-1300-55172026-01-15
00840194498944Response 5.5/6.001-1300-607301-1300-60732026-01-15
00840194498951Response 5.5/6.001-1300-607401-1300-60742026-01-15
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