CRANIOFIX® ABSORBABLE

Primary DI: 04038653348404
Brand: CRANIOFIX® ABSORBABLE
Company: Aesculap AG
Model: FF017
Catalog number: FF017
Device description: 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM
Published: 2015-09-24
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: true
Single use: true

Related Records

Contact Domains

bbraun.com

Product Codes

Code	Name
GXR	COVER, BURR HOLE

Product Code Classifications

Code	Device	Specialty	Class
GXR	Cover, Burr Hole	Neurology	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
04038653348404	Primary	GS1	0
04038653347988	Unit of Use	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	EAN-13
04038653348404	04038653348404	4038653348404
04038653347988	04038653347988	4038653347988

GMDN Terms

Term	Definition
Craniofacial fixation plate, bioabsorbable	A 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 is chemically degraded and typically 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 is constructed of a bioabsorbable synthetic polymer(s); in addition to the plate(s) bioabsorbable bone screws may be included.

Term

Definition

Craniofacial fixation plate, bioabsorbable

A 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 is chemically degraded and typically 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 is constructed of a bioabsorbable synthetic polymer(s); in addition to the plate(s) bioabsorbable bone screws may be included.

Storage And Handling

Type	Low	High	Condition
Special Storage Condition, Specify	0	0
Special Storage Condition, Specify	0	0	Keep away from sunlight
Storage Environment Temperature	25 Degrees Celsius	25 Degrees Celsius

Sterilization Methods

Method

Contacts

Phone	Email
+1(800)282-9000	GUDID.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

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04046964054907	ELAN 4	GA715R	GA715R	2020-04-24
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04046964526213	ECCOS	GB068R	GB068R	2020-04-24
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