FDA.reportPublic FDA data

CRANIOFIX2

Primary DI
04038653402243
Brand
CRANIOFIX2
Company
Aesculap AG
Model
FF492T
Catalog number
FF492T
Device description
CRANIOFIX 2 TITANIUM CLAMP 20MM
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653402243PrimaryGS10
04038653379606Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653402243040386534022434038653402243
04038653379606040386533796064038653379606

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small implantable plate/set of plates designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole; the material cannot be chemically degraded or absorbed by natural body processes. It is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover) and includes implant-grade metal; in addition to the plate(s) bone screws may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
Device count
6
DM exempt
false
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 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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810188324573HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-22
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00810188323767HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
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00810188323873HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810125929274KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-23
00810125929281KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-23
00810188323552HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
00810188323859HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
00810125929229KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
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00810125929267KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810188323828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-20
00810188323811HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323835HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323750HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-17
00810125929168KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929175KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929182KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929199KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929205KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929212KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810188323712HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323736HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323743HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13