FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653379620
Brand
AESCULAP
Company
Aesculap AG
Model
FF494R
Catalog number
FF494R
Device description
"CRANIOFIX2 Applier, 8"", (205 mm), non-sterile, reusable"
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
04038653379620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653379620040386533796204038653379620

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+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
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325068HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325075HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325082HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-17
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324986HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324931HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324979HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324924HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-09
00810188324702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-07
00810188324917HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-06
00810188324818HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324849HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324856HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-26
00810188324672HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324757HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-22
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-09
00810188324689HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-03
00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-06-01
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-28
00810188324634HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-27
08859751210556METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210563METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05
08859751210570METICULY Patient-specific titanium mesh implantMETICULY COMPANY LIMITEDGXN2026-03-05