FDA.reportPublic FDA data

MACS TL

Primary DI
04038653242474
Brand
MACS TL
Company
Aesculap AG
Model
SX797T
Catalog number
SX797T
Device description
MACS TL POLYAXIAL SCREW 7.0X50MM BLUE
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653242474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653242474040386532424744038653242474

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153143758XIA STAINLESS STEELStryker CorporationKWQ2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationKWQ2015-09-14
07613153045670XIA IStryker CorporationKWQ2014-12-08
07613153045700XIA IStryker CorporationKWQ2014-12-08
07613153045724XIA IStryker CorporationKWQ2014-12-08
07613153045731XIA IStryker CorporationKWQ2014-12-08
07613153045748XIA IStryker CorporationKWQ2014-12-08
07613153045755XIA IStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWQ2014-12-08
07613153045793XIA IIStryker CorporationKWQ2014-12-08
07613153045854XIA IIStryker CorporationKWQ2014-12-08
07613153045878XIA IIStryker CorporationKWQ2014-12-08
07613153045885XIA IIStryker CorporationKWQ2014-12-08
07613153045892XIA IIStryker CorporationKWQ2014-12-08
07613153045908XIA IIStryker CorporationKWQ2014-12-08
07613153045915XIA IIStryker CorporationKWQ2014-12-08
07613153045922XIA IIStryker CorporationKWQ2014-12-08
07613153045939XIA IIStryker CorporationKWQ2014-12-08
07613153045960XIA IIStryker CorporationKWQ2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046035XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046042XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046059XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046066XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046073XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046103XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046110XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046127XIA STAINLESS STEELStryker CorporationKWQ2014-12-08
07613153046134XIA STAINLESS STEELStryker CorporationKWQ2014-12-08