FDA.report

LYOPLANT

Primary DI
04038653700950
Brand
LYOPLANT
Company
Aesculap AG
Model
1066048
Catalog number
1066048
Device description
LYOPLANT 4X10CM
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

Product Codes

CodeName
GXQDURA SUBSTITUTE

Product Code Classifications

CodeDeviceSpecialtyClass
GXQDura SubstituteNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653700950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653700950040386537009504038653700950

GMDN Terms

TermDefinition
Dura mater biomatrix implantA bioabsorbable device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). The device is typically in the form of a transparent foil that usually requires no suturing and may be used with fibrin sealant.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
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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04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
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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

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10381780541424Durepair®Integra Lifesciences CorporationGXQ2026-03-11
00813954027210DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
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00813954027234DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
00813954027241DuraMatrix RepairCOLLAGEN MATRIX, INC.GXQ2025-12-10
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10381780540854Durepair™TEI BIOSCIENCES INC.GXQ2025-01-31
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00813954026091DuraMatrix-Onlay ConformCOLLAGEN MATRIX, INC.GXQ2024-02-22
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