FDA.report

Dymaxeon®

Primary DI
00815500021369
Brand
Dymaxeon®
Company
BACK 2 BASIC DIRECT, LLC
Model
05.5
Catalog number
06.6363B
Device description
DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR SCREW Ø5.5 x40mm (BLUE)
Published
2016-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815500021369PrimaryGS10
10815500021366Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815500021369008155000213698155000213690815500021369
1081550002136610815500021366

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Length40Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00devices kept at room temperature or other standard conditions
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(216)447-5025info@back2basicsdirect.com

Regulatory Flags

DUNS number
043841348
Device count
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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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00815500023325Dymaxeon5.506.6541B-12020-03-06
00815500023691Dymaxeon5.546.0725-042020-03-06
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00815500025381Dymaxeon05.546.42412019-03-07
00815500025398Dymaxeon05.546.42422019-03-07
00815500025404Dymaxeon05.546.42432019-03-07
00815500025411Dymaxeon05.546.42442019-03-07
00815500025428Dymaxeon05.546.42452019-03-12
00815500025435Dymaxeon05.546.42462019-03-12
00815500025442Dymaxeon05.546.42472019-03-12
00815500020010Dymaxeon®05.506.1201B2016-01-19
00815500020027Dymaxeon®05.506.1202B2016-01-19
00815500023585Dymaxeon06.009.07112019-03-07
00815500023592Dymaxeon06.009.07122019-03-07
00815500023608Dymaxeon06.009.07132019-03-07
00815500025572Dymaxeon06.009.06732019-03-25

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