FDA.report

Dymaxeon

Primary DI
00815500024445
Brand
Dymaxeon
Company
BACK 2 BASIC DIRECT, LLC
Model
05.5
Catalog number
06.6586B-1
Device description
DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø6.5 x 70mm (GREEN)
Published
2019-01-31
Public version status
New
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815500024445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815500024445008155000244458155000244450815500024445

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
216-447-5025info@back2basicsdirect.com

Regulatory Flags

DUNS number
043841348
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00815500023295Dymaxeon5.506.6340B-12020-03-06
00815500023301Dymaxeon5.506.6341B-12020-03-06
00815500023318Dymaxeon5.506.6540B-12020-03-06
00815500023325Dymaxeon5.506.6541B-12020-03-06
00815500023691Dymaxeon5.546.0725-042020-03-06
00815500023479Dymaxeon05.509.06752019-03-12
00815500025374Dymaxeon05.546.42402019-03-07
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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